- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00000167
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Complications of age-related macular degeneration (AMD) are the leading cause of severe vision loss among people aged 65 and over in the United States and many Western countries. Most, (approximately 90 percent), of this vision loss is due to the neovascular (or wet) form of AMD. The word neovascular describes the development of new, abnormal blood vessels in the back of the eye. Unfortunately, the majority of these new vessels are not amenable to currently available treatments.
The first sign that an eye may develop AMD is the presence of drusen, yellowish deposits under the retina. Current data suggests that eyes with large drusen are at increased risk for developing the vision threatening complications of AMD. Since the 1970s investigators have reported consistently that laser photocoagulation causes a reduction in large drusen. However, results of the effects of laser treatment on preventing later complications of AMD have been less consistent and based on relatively small numbers of patients.
Further study into the ability of a treatment to prevent vision loss from the advanced forms of AMD would have profound public health implications. A treatment that could reduce the risk of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by one half. The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) will assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual acuity.
The CAPT is a multi-center, prospective, randomized clinical trial designed to assess the safety and effectiveness of low-intensity laser treatment in preventing vision loss among patients with large drusen in both eyes. A total of 1052 participants were enrolled in the study. Participants had one eye randomly assigned to laser treatment performed by a CAPT-certified ophthalmologist. The other eye was not treated. Both eyes were observed carefully for any changes for a period of five years. The effectiveness of the treatment was assessed using the following criteria:
Change in visual acuity (primary outcome measure of the study)
Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy
Changes in contrast threshold and critical print size for reading
Quality of life assessments for patients, using the Visual Function Questionnaire 25 (VFQ-25), were conducted at the time of enrollment and at 5 years.
STUDY RESULTS:
Follow-up of patients was excellent; less than 3% of visual acuity examinations were missed. At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had visual acuity scores ≥3 lines worse than at the initial visit (p= 1.00). The cumulative 5-year incidence rates for treated and observed eyes for CNV were 13.3% and 13.3% (p=0.95), respectively; and for GA were 7.4% and 7.8% (p=0.64), respectively. The contrast threshold doubled in 23.9% of treated eyes and in 20.5% of observed eyes (p=0.40). The critical print size doubled in 29.6% of treated eyes and in 28.4% of observed eyes (p=0.70). Seven (0.7%) treated eyes and 14 (1.3%) observed eyes had an adverse event of a ≥6 -line loss in visual acuity in the absence of late age-related macular degeneration or cataract.
As applied in CAPT, low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Arizona
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Mesa, Arizona, Stany Zjednoczone, 85201
- Retinal Consultants of Arizona, Ltd.
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Peoria, Arizona, Stany Zjednoczone, 85351
- Retinal Consultants of Arizona, Ltd.
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California
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San Francisco, California, Stany Zjednoczone, 94107
- West Coast Retina Medical Group, Inc.
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Florida
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Tampa, Florida, Stany Zjednoczone, 33612-4766
- University of South Florida Eye Institute
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory Eye Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
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Harvey, Illinois, Stany Zjednoczone, 60426
- Illinois Retina Associates, S.C.
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Iowa
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Iowa City, Iowa, Stany Zjednoczone, 55242-1091
- University of Iowa
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202-1594
- Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21287-9223
- The Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Ophthalmic Consultants of Boston
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Michigan
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Royal Oak, Michigan, Stany Zjednoczone, 48073
- Associate Retinal Consultants, P.C.
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Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, Stany Zjednoczone, 63110
- Barnes Retina Institute
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New Jersey
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Edison, New Jersey, Stany Zjednoczone, 08820
- Retina-Vitreous Center, P.A.
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Lakewood, New Jersey, Stany Zjednoczone, 08701
- Retina-Vitreous Center, P.A.
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28204
- Southeast Clinical Research Associates
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44122
- Retina Associates of Cleveland
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Columbus, Ohio, Stany Zjednoczone, 43210
- The Ohio State University, Department of Ophthalmology
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97210
- Retina Northwest, P.C.
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Portland, Oregon, Stany Zjednoczone, 97201-4197
- Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Scheie Eye Institute
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Texas
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Dallas, Texas, Stany Zjednoczone, 75231
- Texas Retina Associates
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Wisconsin
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Madison, Wisconsin, Stany Zjednoczone, 53705
- University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Patients eligible for CAPT can be either male or female and meet the following criteria:
Age at least 50 years old
Vision in each eye must measure 20/40 or better.
At least 10 large drusen in each eye
Available for follow-up examinations for 5 years after enrollment
Final eligibility is determined through a detailed eye examination by a CAPT-certified ophthalmologist.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 1
Laser treatment
|
Initial: 60 barely visible burns, grid pattern.
Re-treatment at 12 months: 30 barely visible burns, focal treatment.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
Change in visual acuity (3-line loss)
Ramy czasowe: 5 years
|
5 years
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy
Ramy czasowe: 5 years
|
5 years
|
Changes in contrast threshold and critical print size for reading
Ramy czasowe: 5 years
|
5 years
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Stuart L Fine, MD, Scheie Eye Institute, The University of Pennsylvania School of Medicine
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NEI-70
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Badania kliniczne na Low-Intensity Laser Treatment
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Rhode Island HospitalUniversity of Puerto RicoJeszcze nie rekrutacjaAstma dziecięcaStany Zjednoczone, Portoryko