NCT01968239

Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT

A Randomized, Controlled Interventional Phase 2b (Proof of Concept) Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Ranibizumab Guided by Morphological Changes Documented by Optical Coherence Tomography (OCT) in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).

Detailed description

In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC

Conditions

• Branch Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab	comparison of different re-treatment criteria for intravitreal injection of ranibizumab

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-06-17
• Completion: 2016-12-20
• First posted: 2013-10-23
• Last updated: 2018-12-03

Locations

1 site across 1 country: Germany