Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
연구 개요
상태
상세 설명
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Tokyo, 일본, 101-8309
- Surugadai Nihon university hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Exclusion Criteria:
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
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0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
다른 이름들:
vitrectomy of 25 gauge system.
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가짜 비교기: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
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vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Reoperation
기간: 1 month
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Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
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1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Intra Operative Hemorrhage
기간: End of the surgery.
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Calculate the number of coagulators for the intra operative hemorrhage.
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End of the surgery.
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Postoperative Vitreous Hemorrhage.
기간: 1 month
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Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
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1 month
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Vascular Endothelial Growth Factor Concentration in Vitreous
기간: Start of surgery.
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Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
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Start of surgery.
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Endolaser Photocoagulation
기간: End of surgery.
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Number of intraoperative endolaser photocoagulation.
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End of surgery.
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Iatrogenic Retinal Tears
기간: End of surgery.
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The number of participants who had intraoperative iatrogenic retinal tears.
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End of surgery.
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Surgical Time
기간: End of surgery.
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End of surgery.
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Postoperative Best Corrected Visual Acuity
기간: 1 mouth after surgery.
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Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome. |
1 mouth after surgery.
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Best Corrected Visual Acuity Change
기간: 1 month
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Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome. |
1 month
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Postoperative Neovascular Glaucoma
기간: Within 1 month after the surgery.
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The number of participants with progressive or persistent neovascular glaucoma after surgery.
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Within 1 month after the surgery.
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Elevated Intraocular Pressure
기간: Within 1 month after the surgery.
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The number of participants with elevated intraocular pressure after surgery.
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Within 1 month after the surgery.
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Gas Tamponade
기간: End of surgery.
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The number of participants with gas tamponade at the end of the surgery.
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End of surgery.
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Silicon Oil Tamponade
기간: End of surgery.
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The number of participants with silicon oil tamponade at the end of the surgery.
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End of surgery.
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Ayumu Manabe
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
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