Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT01795209
Phase
PHASE4
Status
Terminated

Conditions

  • Branch Retinal Vein Occlusion
  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit
  • Sham injection — DEVICE
    Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit
  • Rescue laser — PROCEDURE
    In the Lucentis group: performed if BCVA \< 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA \< 20/40 or CFT ≥ 350um from Month 3

Study Details

The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.

Key Dates

First listed
Feb 20, 2013
Start date
Jan 31, 2013
Status verified
Sep 2019
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab group
    Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
  • Sham Comparator: Standard of care group
    Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.

Primary Outcome Measure

Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity [ Time Frame: 1 year ]

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