A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD
연구 개요
상세 설명
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The advanced stages of the disease are characterized by the development of geographic atrophy or choroidal neovascularization, both of which result in significant loss of vision. Development of intravitreal anti-VEGF agents such as ranibizumab has significantly improved outcomes for the neovascular for of the disease. However, it is not possible to predict which individuals will respond to the treatment.
The objective of this study is to establish the association between genetic factors and treatment response to intravitreal Lucentis. This will be accomplished by SNP-genotyping participants for AMD-susceptibility and candidate angiogenesis-pathway genes, collecting environmental risk factor variables and evaluating clinical outcomes. The aim of this pharmacogenetics study will be to identify patients at the outset of their treatment that require more intensive therapy.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- Casey Eye Institute, Oregon Health and Science University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All AMD-related CNV lesion types will be included.
- Age >50 years
- The study eye must never have received treatment for neovascular AMD
- Visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS).
Exclusion Criteria:
- Age <50 years;
- Previous therapy in either eye for AMD or other retinal disease which may be used in the treatment of AMD;
- Choroidal neovascularization not from AMD;
- Concomitant non-AMD related maculopathy in study eye;
- Active treatment for neovascular AMD in fellow eye;
- Acuity loss or central field loss from non-AMD cause;
- Pigment epithelial detachment without evidence of CNV;
- Individuals in whom Lucentis is contraindicated;
- Participation in another clinical trial in last three months
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression'
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
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Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype
기간: 12 months
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12 months
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Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.
기간: 12 months
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12 months
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Median number of intravitreal ranibizumab (Lucentis) injections required per patient
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Peter J Francis, MD PhD, Casey Eye Institute, Oregon Health and Science University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Ranibizumab에 대한 임상 시험
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Novartis완전한
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Pusan National University HospitalNovartis완전한
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University of California, DavisGenentech, Inc.; University of California, San Francisco완전한
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Peter A Campochiaro, MDGenentech, Inc.완전한