- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00000167
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Mesa, Arizona, 미국, 85201
- Retinal Consultants of Arizona, Ltd.
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Peoria, Arizona, 미국, 85351
- Retinal Consultants of Arizona, Ltd.
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California
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San Francisco, California, 미국, 94107
- West Coast Retina Medical Group, Inc.
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Florida
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Tampa, Florida, 미국, 33612-4766
- University of South Florida Eye Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory Eye Center
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Harvey, Illinois, 미국, 60426
- Illinois Retina Associates, S.C.
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Iowa
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Iowa City, Iowa, 미국, 55242-1091
- University of Iowa
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Kentucky
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Louisville, Kentucky, 미국, 40202-1594
- Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine
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Maryland
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Baltimore, Maryland, 미국, 21287-9223
- The Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Ophthalmic Consultants of Boston
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Michigan
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Royal Oak, Michigan, 미국, 48073
- Associate Retinal Consultants, P.C.
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, 미국, 63110
- Barnes Retina Institute
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New Jersey
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Edison, New Jersey, 미국, 08820
- Retina-Vitreous Center, P.A.
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Lakewood, New Jersey, 미국, 08701
- Retina-Vitreous Center, P.A.
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Southeast Clinical Research Associates
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Ohio
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Cleveland, Ohio, 미국, 44122
- Retina Associates of Cleveland
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Columbus, Ohio, 미국, 43210
- The Ohio State University, Department of Ophthalmology
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Oregon
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Portland, Oregon, 미국, 97210
- Retina Northwest, P.C.
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Portland, Oregon, 미국, 97201-4197
- Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Scheie Eye Institute
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Texas
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Dallas, Texas, 미국, 75231
- Texas Retina Associates
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Laser treatment
|
Initial: 60 barely visible burns, grid pattern.
Re-treatment at 12 months: 30 barely visible burns, focal treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in visual acuity (3-line loss)
기간: 5 years
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5 years
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy
기간: 5 years
|
5 years
|
Changes in contrast threshold and critical print size for reading
기간: 5 years
|
5 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Stuart L Fine, MD, Scheie Eye Institute, The University of Pennsylvania School of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
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Low-Intensity Laser Treatment에 대한 임상 시험
-
Rhode Island HospitalUniversity of Puerto Rico아직 모집하지 않음