Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.
A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287
- The Wilmer Eye Institute at Johns Hopkins
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
- Age greater than 50 years.
- Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
- Known hypersensitivity to humanized monoclonal antibodies
- History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
- History of stroke within 6 months of study entry.
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
- History of subfoveal laser treatment in the study eye.
- History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
- Ocular inflammation (including trace or above) in the study eye.
- Inability to comply with study or follow up procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: A
0.3 mg/0.05 ml dose of ranibizumab
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0.3mg/0.05ml 용량
다른 이름들:
0.5mg/0.05ml 용량
다른 이름들:
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실험적: B
0.5 mg/0.05 ml dose of ranibizumab
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0.3mg/0.05ml 용량
다른 이름들:
0.5mg/0.05ml 용량
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
기간: 12 months
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Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study.
The 12 month follow-up visual acuity was subtracted from the baseline visual acuity.
Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retinal Changes on Funduscopy
기간: 12 months
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12 months
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Retinal Thickness Measured by Optical Coherence Tomography (OCT)
기간: 12 months
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12 months
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Fluorescein Leakage on Fluorescein Angiography
기간: 12 months
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12 months
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Number of Subjects Experiencing Complications Related to Drug or Its Administration
기간: 12 months after last injection
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Potential complications included:
Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function. |
12 months after last injection
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NA_00001650
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. .
라니비주맙에 대한 임상 시험
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Novartis완전한
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Hoffmann-La Roche모병신생 혈관 연령 관련 황반 변성벨기에, 미국, 영국, 이탈리아, 아르헨티나, 스페인, 이스라엘, 호주, 오스트리아, 브라질, 독일, 스위스, 대만, 프랑스
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AbbVie모병CNV | AMD | nAMD | 습식 AMD | 습성 연령 관련 황반 변성 | wAMD미국
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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
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Hoffmann-La Roche모병