NCT03637283

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Status
unknown

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

August 15, 2018

Last Update Submit

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

EXPERIMENTAL

vitreoretinal surgery combined with intraoperative anti-VEGF

Procedure: anti-VEGF

fan-shaped photocoagulation

ACTIVE COMPARATOR

vitreoretinal surgery combined with fan-shaped photocoagulation

Procedure: fan-shaped photocoagulation

Interventions

anti-VEGFPROCEDURE

vitreoretinal surgery combined with intraoperative anti-VEGF

anti-VEGF

vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation

fan-shaped photocoagulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Yong Wei, M.D

    The Eye Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

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