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

NCT01795209 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Branch Retinal Vein Occlusion
  • Macular Edema

Interventions

DRUG

Ranibizumab

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

DEVICE

Sham injection

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

PROCEDURE

Rescue laser

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

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Kyu Hyung Park, M.D. · Seoul National Univeristy Bundang Hospital

  • Se Woong Kang, M.D. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795209 on ClinicalTrials.gov