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

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03637283
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 38

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anti-VEGF; Branch Retinal Vein Occlusion; Vitrectomy	Procedure: anti-VEGF; Procedure: fan-shaped photocoagulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
• Anticipated Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anti-VEGF vitreoretinal surgery combined with intraoperative anti-VEGF	Procedure: anti-VEGF; vitreoretinal surgery combined with intraoperative anti-VEGF
Active Comparator: fan-shaped photocoagulation vitreoretinal surgery combined with fan-shaped photocoagulation	Procedure: fan-shaped photocoagulation; vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline in best-corrected visual acuity (BCVA) [3 years]

   Assessed using the ETDRS protocol

Secondary Outcome Measures

1. Mean change from baseline in visual field [3 years]

   Assessed on Humphery(30-2 and 60-4)

2. chang from baseline in structure of retina [3 years]

   Assessed on Optical Coherence Tomography(OCT)

3. chang from baseline in retinal neovascularization [3 years]

   Assessed on Fundus Fluorescein Angiography(FFA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wenzhou Medical University

Investigators

• Principal Investigator: Yong Wei, M.D, The Eye Hospital of Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiangtian Zhou, professor, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT03637283
• Other Study ID Numbers: 10008
• First Posted: Aug 17, 2018
• Last Update Posted: Aug 17, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Vein Occlusion; Vitreous Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Aug 17, 2018