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Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (IVT)

25 августа 2016 г. обновлено: Jaeb Center for Health Research

A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema

The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:

  1. Laser photocoagulation
  2. 1mg intravitreal triamcinolone acetonide injection
  3. 4mg intravitreal triamcinolone acetonide injection

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).

The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.

Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the prevalence of diabetic macular edema is approximately 20% in patients with type 1 diabetes mellitus (DM), 25% in patients with type 2 DM who are taking insulin, and 14% in patients with type 2 DM who do not take insulin.

In a review of three early studies concerning the natural history of diabetic macular edema, Ferris and Patz found that 53% of 135 eyes with diabetic macular edema, presumably all involving the center of the macula, lost two or more lines of visual acuity over a two year period. In the Early Treatment Diabetic Retinopathy Study (ETDRS), 33% of 221 untreated eyes available for follow-up at the 3-year visit, all with edema involving the center of the macula at baseline, had experienced a 15 or more letter decrease in visual acuity score (equivalent to a doubling of the visual angle, e.g., 20/25 to 20/50, and termed "moderate visual acuity loss").

In the ETDRS, focal/grid photocoagulation of eyes with clinically significant macular edema (CSME) reduced the risk of moderate visual loss by approximately 50% (from 24% to 12%, three years after initiation of treatment). Therefore, 12% of treated eyes developed moderate visual loss in spite of treatment. Furthermore, approximately 40% of treated eyes that had retinal thickening involving the center of the macula at baseline still had thickening involving the center at 12 months, as did 25% of treated eyes at 36 months.

Although several treatment modalities are currently under investigation, the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation, as demonstrated by the ETDRS, and intensive glycemic control, as demonstrated by the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS). In the DCCT, intensive glucose control reduced the risk of onset of diabetic macular edema by 23% compared with conventional treatment. Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control, with a 58% risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study.

The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities. One such treatment is pars plana vitrectomy. These studies suggest that vitreomacular traction, or the vitreous itself, may play a role in increased retinal vascular permeability. Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity. However, this treatment may be applicable only to a specific subset of eyes with diabetic macular edema. It also requires a complex surgical intervention with its inherent risks, recovery time, and expense. Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor (VEGF) are under investigation. The use of intravitreal corticosteroids is another treatment modality that has generated recent interest.

The optimal dose of corticosteroid to maximize efficacy with minimum side effects is not known. A 4mg dose of Kenalog is principally being used in clinical practice. However, this dose has been used based on feasibility rather than scientific principles.

There is also experience using Kenalog doses of 1mg and 2mg. These doses anecdotally have been reported to reduce the macular edema. There is a rationale for using a dose lower than 4mg. Glucocorticoids bind to glucocorticoid receptors in the cell cytoplasm, and the steroid-receptor complex moves to the nucleus where it regulates gene expression. The steroid-receptor binding occurs with high affinity (low dissociation constant (Kd) which is on the order of 5 to 9 nanomolar). Complete saturation of all the receptors occurs about 20-fold higher levels, i.e., about 100-200 nanomolar. A 4mg dose of triamcinolone yields a final concentration of 7.5 millimolar, or nearly 10,000-fold more than the saturation dose. Thus, the effect of a 1mg dose may be equivalent to that of a 4mg dose, because compared to the 10,000-fold saturation, a 4-fold difference in dose is inconsequential. It is also possible that higher doses of corticosteroid could be less effective than lower doses due to down-regulation of the receptor. The steroid implant studies provide additional justification for evaluating a lower dose, a 0.5mg device which delivers only 0.5 micrograms per day has been observed to have a rapid effect in reducing macular edema.

There has been limited experience using doses greater than 4mg. Jonas' case series reported results using a 25mg dose. However, others have not been able to replicate this dose using the preparation procedure described by Jonas.

In the trial, 4mg and 1mg doses will be evaluated. The former will be used because it is the dose that is currently most commonly used in clinical practice and the latter because there is reasonable evidence for efficacy and the potential for lower risk. Although there is good reason to believe that a 1mg dose will reduce the macular edema, it is possible that the retreatment rate will be higher with this dose compared with 4mg since the latter will remain active in the eye for a longer duration than the former. Insufficient data are available to warrant evaluating a dose higher than 4mg at this time.

Тип исследования

Интервенционный

Регистрация (Действительный)

840

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Arkansas
      • Little Rock, Arkansas, Соединенные Штаты, 72205-7199
        • Jones Eye Institute/University of Arkansas for Medical Sciences
    • California
      • Baldwin Park, California, Соединенные Штаты, 91706
        • SCPMG Regional Offices - Kaiser Permanente
      • Beverly Hills, California, Соединенные Штаты, 90211
        • Retina-Vitreous Associates Medical Group
      • Irvine, California, Соединенные Штаты, 92697
        • University of California, Irvine
      • Loma Linda, California, Соединенные Штаты, 92354
        • Loma Linda University Health Care, Dept. of Ophthalmology
      • Los Angeles, California, Соединенные Штаты, 90033
        • Doheny Eye Institute
      • Los Angeles, California, Соединенные Штаты, 90095
        • Jules Stein Eye Institute
      • Palm Springs, California, Соединенные Штаты, 92262
        • Southern California Desert Retina Consultants, MC
      • San Francisco, California, Соединенные Штаты, 94107
        • West Coast Retina Medical Group, Inc.
      • Santa Ana, California, Соединенные Штаты, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, Соединенные Штаты, 93103
        • California Retina Consultants
      • Walnut Creek, California, Соединенные Штаты, 94598
        • Bay Area Retina Associates
    • Colorado
      • Denver, Colorado, Соединенные Штаты, 80204
        • Denver Health Medical Center
      • Louisville, Colorado, Соединенные Штаты, 80027
        • Eldorado Retina Associates, P.C.
    • Connecticut
      • New Haven, Connecticut, Соединенные Штаты, 06519-1600
        • Connecticut Retina Consultants
      • New Haven, Connecticut, Соединенные Штаты, 06519
        • Connecticut Retina Consultants
    • Florida
      • Fort Myers, Florida, Соединенные Штаты, 33912
        • National Ophthalmic Research Institute
      • Ft. Lauderdale, Florida, Соединенные Штаты, 33334
        • Retina Group of Florida
      • Lakeland, Florida, Соединенные Штаты, 33805
        • Central Florida Retina Institute
      • Lakeland, Florida, Соединенные Штаты, 33805
        • Florida Retina Consultants
      • Sarasota, Florida, Соединенные Штаты, 34239
        • Sarasota Retina Institute
      • Tampa, Florida, Соединенные Штаты, 33603
        • International Eye Center
    • Georgia
      • Augusta, Georgia, Соединенные Штаты, 30909
        • Southeast Retina Center, P.C.
    • Hawaii
      • Aiea, Hawaii, Соединенные Штаты, 96701
        • Retina Consultants of Hawaii, Inc.
      • Honolulu, Hawaii, Соединенные Штаты, 96813
        • Retina Associates of Hawaii, Inc.
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Соединенные Штаты, 60611
        • Northwestern Medical Faculty Foundation
      • Joliet, Illinois, Соединенные Штаты, 60435
        • Illinois Retina Associates
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46290
        • Raj K. Maturi, M.D., P.C.
      • New Albany, Indiana, Соединенные Штаты, 47150
        • John-Kenyon American Eye Institute
    • Kentucky
      • Lexington, Kentucky, Соединенные Штаты, 40509-1802
        • Retina and Vitreous Associates of Kentucky
      • Paducah, Kentucky, Соединенные Штаты, 42001
        • Paducah Retinal Center
    • Maine
      • Bangor, Maine, Соединенные Штаты, 04401
        • Maine Vitreoretinal Consultants
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21237
        • Elman Retina Group, P.A.
      • Baltimore, Maryland, Соединенные Штаты, 21287-9277
        • Wilmer Ophthalmological Institute at Johns Hopkins
      • Greenbelt, Maryland, Соединенные Штаты, 20770-3502
        • The Retina Group of Washington
      • Salisbury, Maryland, Соединенные Штаты, 21801
        • Retina Consultants of Delmarva, P.A.
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02215
        • Joslin Diabetes Center
      • Boston, Massachusetts, Соединенные Штаты, 02114
        • Ophthalmic Consultants of Boston
    • Michigan
      • Detroit, Michigan, Соединенные Штаты, 48202
        • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
      • Detroit, Michigan, Соединенные Штаты, 48201-1423
        • Kresge Eye Institute
      • Grand Rapids, Michigan, Соединенные Штаты, 49546
        • Associated Retinal Consultants
      • Royal Oak, Michigan, Соединенные Штаты, 48073
        • Vision Research Foundation
    • Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты, 55404
        • Retina Center, PA
    • Missouri
      • St. Louis, Missouri, Соединенные Штаты, 63110
        • Barnes Retina Institute
      • St. Louis, Missouri, Соединенные Штаты, 63104
        • St. Louis University Eye Institute
    • New Jersey
      • Lawrenceville, New Jersey, Соединенные Штаты, 08648
        • Delaware Valley Retina Associates
    • New York
      • New York, New York, Соединенные Штаты, 10003
        • The New York Eye and Ear Infirmary/Faculty Eye Practice
      • Rochester, New York, Соединенные Штаты, 14642
        • University of Rochester
      • Slingerlands, New York, Соединенные Штаты, 12159
        • Retina Consultants, PLLC
      • Syracuse, New York, Соединенные Штаты, 13224
        • Retina-Vitreous Surgeons of Central New York, PC
    • North Carolina
      • Chapel Hill, North Carolina, Соединенные Штаты, 27599
        • University of North Carolina, Dept. of Ophthalmology
      • Charlotte, North Carolina, Соединенные Штаты, 28210
        • Charlotte Eye Ear Nose and Throat Assoc, PA
      • Charlotte, North Carolina, Соединенные Штаты, 28211
        • Horizon Eye Care, PA
      • Winston-Salem, North Carolina, Соединенные Штаты, 27157
        • Wake Forest University Eye Center
    • Ohio
      • Beachwood, Ohio, Соединенные Штаты, 44122
        • Retina Associates of Cleveland, Inc.
      • Cleveland, Ohio, Соединенные Штаты, 44106
        • Case Western Reserve University
      • Dublin, Ohio, Соединенные Штаты, 43017
        • OSU Eye Physicians and Surgeons, LLC.
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73104
        • Dean A. McGee Eye Institute
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Casey Eye Institute
      • Portland, Oregon, Соединенные Штаты, 97210
        • Retina Northwest, PC
    • Pennsylvania
      • Hershey, Pennsylvania, Соединенные Штаты, 17033
        • Penn State College of Medicine
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • University of Pennsylvania Scheie Eye Institute
    • Rhode Island
      • Providence, Rhode Island, Соединенные Штаты, 02903
        • Retina Consultants
    • South Carolina
      • Columbia, South Carolina, Соединенные Штаты, 29223
        • Carolina Retina Center
      • Columbia, South Carolina, Соединенные Штаты, 29169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, Соединенные Штаты, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Knoxville, Tennessee, Соединенные Штаты, 37909
        • Southeastern Retina Associates, P.C.
      • Nashville, Tennessee, Соединенные Штаты, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Abilene, Texas, Соединенные Штаты, 79605
        • West Texas Retina Consultants P.A.
      • Arlington, Texas, Соединенные Штаты, 76012
        • Texas Retina Associates
      • Austin, Texas, Соединенные Штаты, 78705
        • Retina Research Center
      • Dallas, Texas, Соединенные Штаты, 75231
        • Texas Retina Associates
      • Galveston, Texas, Соединенные Штаты, 77555-1106
        • University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences
      • Houston, Texas, Соединенные Штаты, 77030
        • Retina Consultants of Houston, PA
      • Houston, Texas, Соединенные Штаты, 77025
        • Retina and Vitreous of Texas
      • Houston, Texas, Соединенные Штаты, 77002
        • Charles A. Garcia, PA & Associates
      • Lubbock, Texas, Соединенные Штаты, 79424
        • Texas Retina Associates
      • McAllen, Texas, Соединенные Штаты, 78503
        • Valley Retina Institute
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84107
        • Rocky Mountain Retina Consultants
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Соединенные Штаты, 53705
        • University of Wisconsin-Madison, Dept. of Ophthalmology
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Medical College of Wiconsin

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

To be eligible, the following inclusion criteria must be met:

  1. Age ≥18 years
  2. Diagnosis of diabetes mellitus (type 1 or type 2)
  3. Able and willing to provide informed consent.
  4. Patient understands that (1) if both eyes are eligible at the time of randomization, one eye will receive intravitreal triamcinolone acetonide and one eye will receive laser, and (2) if only one eye is eligible at the time of randomization and the fellow eye develops DME later, then the fellow eye will not receive intravitreal triamcinolone acetonide if the study eye received intravitreal triamcinolone acetonide (however, if the study eye was assigned to the laser group, then the fellow eye may be treated with the 4mg dose of the study intravitreal triamcinolone acetonide formulation, provided the eye assigned to laser has not received an intravitreal injection; such an eye will not be a "study eye" but since it is receiving study drug, it will be followed for adverse effects).

Exclusion Criteria

A patient is not eligible if any of the following exclusion criteria are present:

7. History of chronic renal failure requiring dialysis or kidney transplant.

8. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Note: Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.

9. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.

10. Known allergy to any corticosteroid or any component of the delivery vehicle.

11. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.

12. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.

13. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). Note: If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.

Study Eye Eligibility

Inclusion

  1. Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (e-ETDRS) visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤73 letters (i.e., 20/40 or worse).
  2. Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
  3. Mean retinal thickness on two Optical Coherence Tomography (OCT) measurements ≥250 microns in the central subfield.

  4. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.

    Exclusion

  5. Macular edema is considered to be due to a cause other than diabetic macular edema.
  6. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
  7. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
  8. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
  9. History of prior treatment with intravitreal corticosteroids.
  10. History of peribulbar steroid injection within 6 months prior to randomization.
  11. History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.Note: Patients are not required to have had prior macular photocoagulation to be enrolled. If prior macular photocoagulation has been performed, the investigator should believe that the patient may possibly benefit from additional photocoagulation.
  12. History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization.
  13. Anticipated need for PRP in the 4 months following randomization.
  14. History of prior pars plana vitrectomy.
  15. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 6 months following randomization.
  16. History of YAG capsulotomy performed within 2 months prior to randomization.
  17. Intraocular pressure ≥25 mmHg.
  18. History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma.) Note: Angle-closure glaucoma is not an exclusion. A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure (IOP) is <25 mm Hg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous. If the intraocular pressure is 22 to <25 mm Hg, then the above criteria for ocular hypertension eligibility must be met.
  19. History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
  20. History of prior herpetic ocular infection.
  21. Exam evidence of ocular toxoplasmosis.
  22. Aphakia.
  23. Exam evidence of pseudoexfoliation.
  24. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.

In patients with only one eye meeting criteria to be a study eye at the time of randomization, the fellow eye must meet the following criteria:

  1. Best corrected e-ETDRS visual acuity score ≥19 letters (i.e., 20/400 or better).
  2. No prior treatment with intravitreal corticosteroids.
  3. Intraocular pressure < 25 mmHg.
  4. No history of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma.)Note: Angle-closure glaucoma is not an exclusion. A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure is <25 mmHg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous. If the intraocular pressure is 22 to <25 mmHg, then the above criteria for ocular hypertension eligibility must be met.
  5. No history of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
  6. No exam evidence of pseudoexfoliation.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 1
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Процедура: Standard of Care Group
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Другие имена:
  • soc with laser
  • modified ETDRS photocoagulation
Экспериментальный: 2
Intravitreal injection of 1mg of triamcinolone acetonide
Лекарство: 1mg triamcinolone acetonide
Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
Другие имена:
  • кортикостероид
Экспериментальный: 3
Intravitreal injection of 4mg of triamcinolone acetonide
Лекарство: 4mg triamcinolone acetonide
4mg intravitreal triamcinolone acetonide injection at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
Другие имена:
  • кортикостероид

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Временное ограничение: Baseline to 2 Years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Baseline to 2 Years
Median Change in Visual Acuity Baseline to 2 Years
Временное ограничение: Baseline to 2 Years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Baseline to 2 Years
Distribution of Change in Visual Acuity Baseline to 2 Years
Временное ограничение: baseline to 2 years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
baseline to 2 years

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Central Subfield Thickness at 2 Years
Временное ограничение: 2 Years
Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
2 Years
Mean Change in Central Subfield Thickness Baseline to 2 Years
Временное ограничение: Baseline to 2 years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.
Baseline to 2 years
Median Change in Central Subfield Thickness Baseline to 2 Years
Временное ограничение: Baseline to 2 Years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Baseline to 2 Years
Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Временное ограничение: Baseline to 2 Years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Baseline to 2 Years
Central Subfield Thickness < 250 Microns at 2 Years
Временное ограничение: 2 Years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
2 Years
Change in Visual Acuity From Baseline to 3 Years
Временное ограничение: Baseline to 3 year
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Baseline to 3 year
Change in Visual Acuity From Baseline to 3 Years
Временное ограничение: Baseline to 3 year
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0
Baseline to 3 year
Distribution of Visual Acuity Change Baseline to 3 Years
Временное ограничение: Baseline to 3 years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0
Baseline to 3 years
Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
Временное ограничение: 3 years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
3 years
Change in Central Subfield Thickness on OCT Baseline to 3 Years
Временное ограничение: Baseline to 3 years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Baseline to 3 years
Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
Временное ограничение: Baseline to 3 years
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Baseline to 3 years

Соавторы и исследователи

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Спонсор

Jaeb Center for Health Research

Соавторы

National Eye Institute (NEI)
Allergan

Следователи

  • Учебный стул: Michael Ip, M.D., University of Wisconsin Medical School

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2004 г.

Первичное завершение (Действительный)

1 мая 2008 г.

Завершение исследования (Действительный)

1 октября 2008 г.

Даты регистрации исследования

Первый отправленный

3 августа 2006 г.

Впервые представлено, что соответствует критериям контроля качества

18 августа 2006 г.

Первый опубликованный (Оценивать)

22 августа 2006 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

26 августа 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2016 г.

Последняя проверка

1 августа 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NEI-105
  • U10EY018817-03 (Грант/контракт NIH США)
  • U10EY014231-09 (Грант/контракт NIH США)
  • U10EY014229-07 (Грант/контракт NIH США)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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