Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
- Sponsor
- University of Leipzig
- Study ID
- NCT01968239
- Phase
- PHASE2
- Status
- Completed
Conditions
- Branch Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab — DRUGcomparison of different re-treatment criteria for intravitreal injection of ranibizumab
Study Details
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).
Key Dates
- First listed
- Oct 23, 2013
- Start date
- Oct 31, 2013
- Status verified
- Nov 2018
- Primary completion
- Jun 17, 2016
- Completion
- Dec 20, 2016
Study Design
- Enrollment
- 27 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: OCT guided groupPatients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT.
- Active Comparator: Standard treatmentPatients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected).
Primary Outcome Measure
change of best corrected visual acuity (BCVA) measured in ETDRS letters [ Time Frame: 12 months ]