Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

25. august 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

840

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 1
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Fremgangsmåte: Standard of Care Group
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Andre navn:
  • soc with laser
  • modified ETDRS photocoagulation
Eksperimentell: 2
Intravitreal injection of 1mg of triamcinolone acetonide
Legemiddel: 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.
Andre navn:
  • kortikosteroid
Eksperimentell: 3
Intravitreal injection of 4mg of triamcinolone acetonide
Legemiddel: 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.
Andre navn:
  • kortikosteroid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Central Subfield Thickness at 2 Years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jaeb Center for Health Research

Samarbeidspartnere

National Eye Institute (NEI)
Allergan

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2004

Primær fullføring (Faktiske)

1. mai 2008

Studiet fullført (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først innsendt

3. august 2006

Først innsendt som oppfylte QC-kriteriene

18. august 2006

Først lagt ut (Anslag)

22. august 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NEI-105
  • U10EY018817-03 (U.S. NIH-stipend/kontrakt)
  • U10EY014231-09 (U.S. NIH-stipend/kontrakt)
  • U10EY014229-07 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere