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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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: Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome) 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 Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months Pregnancy (positive pregnancy test) or lactation History of allergy to humanized antibodies or any component of the ranibizumab formulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT guided group<br>Patients 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. | Drug: Ranibizumab<br>* comparison of different re-treatment criteria for intravitreal injection of ranibizumab<br>|
| Active Comparator: Standard treatment<br>Patients 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). | Drug: Ranibizumab<br>* comparison of different re-treatment criteria for intravitreal injection of ranibizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of best corrected visual acuity (BCVA) measured in ETDRS letters |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central retinal thickness (CRT) |  | 12 months | 
| Number of applied ranibizumab injections |  | 12 months | 
| • Rates of patients developing a neovascularisation of the retina/ anterior segment |  | 12 months | 
| Assessment of safety: serious adverse events/ reactions; AEs/ARs |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRVO, Macular edema, Ranibizumab, re-treatment