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NCT03637283 Clinical Trial

Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

Branch Retinal Vein Occlusion Clinical Trial

Official title:
Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03637283
Other study ID # 10008
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2021

Study information
Verified date August 2018
Source Wenzhou Medical University
Contact Yong Wei, M.D
Phone +86 15057551266
Email weiyongdoctor@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Age = 18 years old;

2. BRVO is diagnosed

3. Vitreous hemorrhage

4. Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)

Exclusion Criteria:

1. BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )

2. BRVO combined with retinal detachment

3. Retinal veins are completely whitened

4. iris neovascularization or neovascular glaucoma

5. Combined glaucoma

6. combined with other retinopathy

7. Received anti-VEGF treatment within 3 months before surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• anti-VEGF
vitreoretinal surgery combined with intraoperative anti-VEGF
• fan-shaped photocoagulation
vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wenzhou Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline in best-corrected visual acuity (BCVA) Assessed using the ETDRS protocol 3 years
Secondary Mean change from baseline in visual field Assessed on Humphery(30-2 and 60-4) 3 years
Secondary chang from baseline in structure of retina Assessed on Optical Coherence Tomography(OCT) 3 years
Secondary chang from baseline in retinal neovascularization Assessed on Fundus Fluorescein Angiography(FFA) 3 years
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