ong-term need of Ranibizumab injections with or without early targeted peripheral laser photocoagulation for treatment of macular edema due to central retinal vein occlusion (CoRaLa II trial)

Phase 1

Recruiting

• Conditions: Macular edema due to central retinal vein occlusion; MedDRA version: 20.0Level: LLTClassification code: 10007972Term: Central retinal vein occlusion Class: 10015919; MedDRA version: 20.0Level: LLTClassification code: 10054467Term: Macular edema Class: 10015919; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2023-507816-11-00
• Lead Sponsor: Justus-Liebig-Universitaet Giessen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

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, 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., 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified