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

Sponsor

University of Leipzig (Other)

Overall Status

Completed

CT.gov ID

NCT01968239

Collaborator

(none)

Enrollment

Location

Arms

38.6

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Drug: Ranibizumab	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jun 17, 2016

Actual Study Completion Date :

Dec 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCT guided group 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 comparison of different re-treatment criteria for intravitreal injection of ranibizumab
Active Comparator: Standard treatment 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 comparison of different re-treatment criteria for intravitreal injection of ranibizumab

Arm

Intervention/Treatment

Experimental: OCT guided group

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

comparison of different re-treatment criteria for intravitreal injection of ranibizumab

Active Comparator: Standard treatment

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

comparison of different re-treatment criteria for intravitreal injection of ranibizumab

Outcome Measures

Primary Outcome Measures

change of best corrected visual acuity (BCVA) measured in ETDRS letters [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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