- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00892398
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.
The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.
The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T2M4
- Maisonneuve-Rosemont Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- to have uncontrolled glaucoma
- to have accepted to undergo a primary trabeculectomy with mitomycin C
to have one of the following types of glaucoma:
- Normal tension Glaucoma
- Chronic Open-Angle Glaucoma
- Chronic Angle-Closure Glaucoma
- Mixed mechanism glaucoma
- Steroid-induced Glaucoma
- Neovascular Glaucoma
Exclusion Criteria:
- to be less than 18 years old
- to be unable to observe the study protocol
- to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
- a history of thromboembolic events and cerebrovascular accidents
- congenital glaucoma
- uveitic glaucoma
- to be pregnant
- to be breastfeeding
- surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
- to have undergone a previous conjunctival surgery
- to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
- to present an active or suspected intraocular or periocular inflammation
- to have a kidney failure
- to have a liver failure
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 |
|---|---|
|
실험적: ranibizumab
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
|
Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL).
The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.
|
|
활성 비교기: standard care
Trabeculectomy with mitomycin C and standard post-operative care
|
standard post-operative care after trabeculectomy with mitomycin C
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Failure rates of the surgery as defined by intraocular pressure reductions
기간: one year
|
Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications.
Qualified success: similar definition with the use of glaucoma medications.
|
one year
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Bleb morphology using Moorfields bleb grading system
기간: one year
|
one year
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Gisele Li, M.D., Maisonneuve-Rosemont Hospital
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. .