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

Branch Retinal Vein Occlusion Clinical Trial

— RabOCT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968239
• Other study ID #: 201200543910
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: December 20, 2016

Study information

• Verified date: November 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 20, 2016
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
comparison of different re-treatment criteria for intravitreal injection of ranibizumab

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of best corrected visual acuity (BCVA) measured in ETDRS letters		12 months
Secondary	Central retinal thickness (CRT)		12 months
Secondary	Number of applied ranibizumab injections		12 months
Secondary	• Rates of patients developing a neovascularisation of the retina/ anterior segment		12 months
Secondary	Assessment of safety: serious adverse events/ reactions; AEs/ARs		12 months