Clinical trial NCT01968239: Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Branch Retinal Vein Occlusion
Keywords: BRVO
Macular edema
Ranibizumab
re-treatment
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility 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

Primary outcomes:
measure: change of best corrected visual acuity (BCVA) measured in ETDRS letters
timeFrame: 12 months
Secondary outcomes:
measure: Central retinal thickness (CRT)
timeFrame: 12 months
measure: Number of applied ranibizumab injections
timeFrame: 12 months
measure: • Rates of patients developing a neovascularisation of the retina/ anterior segment
timeFrame: 12 months
measure: Assessment of safety: serious adverse events/ reactions; AEs/ARs
timeFrame: 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Ophthalmology, University Leipzig
Study officials:
affiliation: Department of Ophthalmology, University of Leipzig, Germany
name: Matus Rehak, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: