Macular edema due to central retinal vein occlusion MedDRA version: 20.0 Level: LLT Classification code 10054467 Term: Macular edema System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Lucentis
Product Name: Ranibizumab
Pharmaceutical Form: Injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
Justus-Liebig University Gießen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of macular edema due to central retinal vein occlusion foveal thickness >250 µm (measured by optical coherence tomography (OCT)) 2. Age ? 18 years 3. Written informed consent of the patient 4. Best corrected visual acuity (BCVA) score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart 5. History of central retinal vein occlusion (CRVO) no longer than 6 months 6. Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field fluorescein angiography 7. 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) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: 1. CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters 2. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome) 3. History of idiopathic central serous chorioretinopathy 4. Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT 5. 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 6. Aphakia in the study eye 7. Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry 8. Intraocular or periocular injection of steroids in the study eye prior to study entry 9. Previous use of an anti-VEGF drug in the study eye 10. Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry 11. Uncontrolled glaucoma (defined as intraocular pressure = 30 mmHg despite treatment with maximal anti-glaucoma medications) 12. History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study 13. Pregnancy (positive urine pregnancy test) or lactation 14. The presence of active malignancy, including lymphoproliferative disorders. 15. History of allergy to fluorescein or a component of the ranibizumab formulation 16. Active intraocular infection 17. Participation in another simultaneous interventional medical investigation or trial 18. 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: The primary objective is to evaluate whether or not the duration of guideline-conform periodic ranibizumab injections may be shortened or even be successfully terminated in patient with macular edema due to central retinal vein occlusion if early targeted peripheral laser photocoagulation is applied in parallel. ;Secondary Objective: Secondary objectives are to evaluate the visual acuity during and after the course of intervention, quality of life associated aspects and possible problems which might possibly be associated with the trial’s Intervention.;Primary end point(s): Primary efficacy endpoint is the time to treatment success, defined as time from randomisation until the date of last criteria-based intravitreal injection in case that thereafter a treatment-free period for (at least) 6 months was observed.;Timepoint(s) of evaluation of this end point: At each mandatory visit (Monthly between Month 1 to Month 12 and then at Months 16, 20, 24 and 29) at the latest at Months 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints (sEP) are: • the best corrected visual acuity (BCVA) • central subfield thickness (CST) • the number of ranibizumab injections required until treatment success and up to the end of observation. • the proportion of subjects developing neovascularization(s) over total observation period. ;Timepoint(s) of evaluation of this end point: At each mandatory visit (Monthly between Month 1 to Month 12 and then at Months 16, 20, 24 and 29) at the latest at Months 29 | — |
Countries
Austria, Germany
Contacts
Public ContactDepartment of Ophthalmology
Justus-Liebig-Universität
Outcome results
None listed