Overview

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

Status:
Completed
Trial end date:
2016-12-20
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leipzig
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

- Recurrence of macular edema defined as any kind of fluid accumulation in the macula
(microcystic changes with or without increase of central retinal thickness) detected
by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of
BCVA measured with ETDRS charts 2. Diagnosis of BRVO with macular edema treated with
at least three intravitreally applied injections of ranibizumab after the up-load
phase of treatment 3. Age ≥ 18 years 4. Ability and willingness to attend all
scheduled visits and assessments 5. For sexually active women of childbearing
potential, use of an appropriate form of contraception (or abstinence) for the
duration of the study

Exclusion Criteria:

1. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic
maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)

2. Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular
traction, epiretinal membrane), either on clinical examination or OCT, thought to be
contributing to macular edema

3. Use of intraocular or periocular injection of steroids in the study eye (e.g.,
triamcinolone) prior to study entry

4. History of cerebral vascular accident, myocardial infarction, transient ischemic
attacks in last 6 months

5. Pregnancy (positive pregnancy test) or lactation

6. History of allergy to humanized antibodies or any component of the ranibizumab
formulation