Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 17, 2018
August 1, 2018
2.2 years
August 15, 2018
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
3 years
Secondary Outcomes (3)
Mean change from baseline in visual field
3 years
chang from baseline in structure of retina
3 years
chang from baseline in retinal neovascularization
3 years
Study Arms (2)
anti-VEGF
EXPERIMENTALvitreoretinal surgery combined with intraoperative anti-VEGF
fan-shaped photocoagulation
ACTIVE COMPARATORvitreoretinal surgery combined with fan-shaped photocoagulation
Interventions
vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old;
- BRVO is diagnosed
- Vitreous hemorrhage
- Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)
You may not qualify if:
- 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 )
- BRVO combined with retinal detachment
- Retinal veins are completely whitened
- iris neovascularization or neovascular glaucoma
- Combined glaucoma
- combined with other retinopathy
- Received anti-VEGF treatment within 3 months before surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Wei, M.D
The Eye Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 15, 2018
First Posted
August 17, 2018
Study Start
October 1, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
August 17, 2018
Record last verified: 2018-08