macular edema secondary to branch retinal vein occlusion (BRVO) MedDRA version: 18.1 Level: LLT Classification code 10054467 Term: Macular edema System Organ Class: 100000004853 MedDRA version: 18.1 Level: LLT Classification code 10038906 Term: Retinal vein branch occlusion System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Lucentis (Ranibizumab)
Product Name: Ranibizumab
Pharmaceutical Form: Solution for injection
Sponsors
University of Leipzig Ritterstr. 26, 04109 Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed up-load phase of ranibizumab treatment (at least 3 monthly intravitreal injections) due to macular edema secondary to branch retinal vein occlusion with presence of recurrence of macular edema detected by optical coherence tomography (OCT) without decrease of BCVA score more than 3 ETDRS letters when compared with BCVA on day of 3rd ranibizumab application 2. BCVA score in the study eye between 20 letters (20/400) and 78 letters (20/32) measured in ETDRS chart and foveal thickness = 250 µm (measured by OCT) and prior to the first ranibizumab injection 3. Age = 18 years 4. Written informed consent of the patient 5. The history of BRVO no longer than 8 months prior to the first ranibizumab injection 6. Ability and willingness to attend all scheduled visits and assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
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. An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates 4. Aphakia 5. Macular laser photocoagulation in the study eye prior to study entry 6. Use of intraocular or periocular injection of steroids in the study eye prior to study entry 7. Cataract surgery or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry 8. History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months prior to randomization 9. The presence of active malignancy 10. Pregnancy (positive pregnancy test) or lactation 11. History of allergy to humanized antibodies or any component of the ranibizumab formulation 12. Participation in another simultaneous medical investigation or trial 13. Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is the efficacy endpoint which is the change of best corrected visual acuity (BCVA) measured in ETDRS letters. ;Secondary Objective: •Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 52 (EoS). •Number of Ranibizumab injections applied per patients in total; maximally 11 injections may be applied based on standardized arm-specific retreatment criteria. •Rate of patients per group progressing to neovascularization of the retina or anterior segment which require pan-retinal photocoagulation. •Number of serious adverse events (SAEs)/ reactions (SARs – causally related to treatments) per group and •Number of adverse events (AEs)/ reactions (ARs) per group observed during the entire course of study. ;Primary end point(s): Based on the BCVA assessment of the study eye - performed at all study visits and measured in ETDRS letters - the primary end point will be derived. For confirmatory analysis the change score in BCVA from within 12 months, i.e. end of study (EoS), will be calculated. ;Timepoint(s) of evaluation of this end point: End of study for each patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 52 (EoS). • Number of Ranibizumab injections applied per patients in total; maximally 11 injections may be applied based on standardized arm-specific retreatment criteria. • Rate of patients per group progressing to neovascularization of the retina or anterior segment which require pan-retinal photocoagulation. • Number of serious adverse events (SAEs)/ reactions (SARs – causally related to treatments) per group and • Number of adverse events (AEs)/ reactions (ARs) per group observed during the entire course of study. ;Timepoint(s) of evaluation of this end point: End of study for each patient | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Department of Ophthalmology, Universtity of Leipzig
Outcome results
None listed