Ranibizumab Injection: initial three injections of Ranibizumab - afterwards pro re nata monthly
Laser photocoagulation: Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times
Study summary
Intravitreal injections of Ranibizumab will be applied in all patients according to treatment guidelines. The experimental group will receive additional targeted laser photocoagulation of the peripheral areas of capillary non-perfusion (up to 4 laser treatments within 1st year of the study). Based on the long-term observation after CoRaLa I study an importantly shorter duration of treatment and a relevant reduction of the total number of re-injections in RL patients is expected.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosis of macular edema due to central retinal vein occlusion foveal thickness \> 250 μm (measured by OCT)
* Age \> 18 years
* Written informed consent of the patient
* BCVA score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart
* History of CRVO no longer than 6 months
* Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field fluorescein angiography
* Ability and willingness to attend all scheduled visits and assessments
Exclusion Criteria:
* CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters
* Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
* History of idiopathic central serous chorioretinopathy
* Presence of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
* 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
* Aphakia in the study eye
* Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
* Intraocular or periocular injection of steroids in the study eye prior to study entry
* Previous use of an anti-VEGF drug in the study eye
* Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry
* Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mm Hg despite treatment with maximal anti-glaucoma medications)
* History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study
* Pregnancy (positive urine pregnancy test) or lactation
* The presence of active malignancy, including lymphoproliferative disorders.
* History of allergy to fluorescein or any component of the ranibizumab formulation
* Active intraocular infection
* Participation in another simultaneous interventional medical investigation or trial
* 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.
Primary outcome measure(s)
Efficacy endpoint is the time to treatment success — up-to 29 months 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.
Trial sites (12)
Facility
City
Region
Status
Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie
Innsbruck
Austria
Universitätsklinikum Klinik für Augenheilkunde Freiburg
Freiburg im Breisgau
Germany
Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde
Giessen
Germany
Hannover MHH Universitätsklinik für Augenheilkunde
Hanover
Germany
University Hospital of Leipzig Department of Ophthalmology
Leipzig
Germany
Klinikum der Stadt Ludwigshafen Augenklinik
Ludwigshafen
Germany
Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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