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

PHASE4TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Branch Retinal Vein OcclusionMacular 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"

Trial Locations (2)

463-707

Seoul National University Bundang Hospital, Seongnam

135-710

Samsung Medical Center, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Samsung Medical Center

OTHER

collaborator

Novartis

INDUSTRY

lead

Seoul National University Bundang Hospital

OTHER

NCT01795209 - Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision | Biotech Hunter | Biotech Hunter