CompletedPhase 2

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

Germany27 participantsStarted 2013-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

change of best corrected visual acuity (BCVA) measured in ETDRS letters

Timeframe: 12 months

Trial details

NCT IDNCT01968239

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06-17

View on ClinicalTrials.gov More Branch Retinal Vein Occlusion trials