Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy (RANTA)
Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
연구 개요
상세 설명
Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.
The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국
- Beijing Aier Intech Eye Hospital
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Guangdong
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Guanzhou, Guangdong, 중국
- Guangzhou Aier Eye Hospital
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Shenzhen, Guangdong, 중국, 510000
- Shenzhen Aier Eye Hospital
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Shenzhen, Guangdong, 중국, 528000
- Shenzhen Eye Hospital
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Heilongjiang
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Harbin, Heilongjiang, 중국
- Harbin Aier Eye Hospital
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Hubei
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Wuhan, Hubei, 중국
- Wuhan General Hospital of Pla
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Zhejiang
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Wenzhou, Zhejiang, 중국, 325027
- The Eye Hospital of Wenzhou Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent);
- a greatest lineardimensionof the lesion of <5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA;
- Cross-reading by different center to confirmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperfluorescence (appearing within the first 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypofluorescent halo (in first 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (defined as size of hemorrhage of at least 4 disk areas).
Exclusion Criteria:
- received treatment previously with verteporfin PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment;
- a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia;
- experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma;
- undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)
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: Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
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Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
다른 이름들:
Intravitreal inject 0.5mg of Ranibizumab.
다른 이름들:
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활성 비교기: Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
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Intravitreal inject 0.5mg of Ranibizumab.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of mean BCVA
기간: 12 months
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Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of Central Rerina Thickness
기간: 12 months
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Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
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12 months
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regression of Branch vacular network(BVN)
기간: 12 months
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Size of Branch vascular network (um)
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12 months
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Polyps regression
기간: 12 months
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Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
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12 months
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Number of re-treatments
기간: 12 month
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re-treatments numbers
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12 month
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공동 작업자 및 조사자
수사관
- 연구 의자: Shibo Tang, Aier School of Ophthalmology, Central South University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB2016006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Triamcinolone Acetonide에 대한 임상 시험
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Navamindradhiraj University완전한
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Ain Shams University아직 모집하지 않음
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University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.완전한
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Tanta University아직 모집하지 않음
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University of Sao Paulo알려지지 않은