RecruitingPhase 3NCT04444492

Combination of Ranibizumab and Targeted Laser Photocoagulation

Long-term Need of Ranibizumab Injections With or Without Early Targeted Peripheral Laser Photocoagulation for Treatment of Macular Edema Due to Central Retinal Vein Occlusion


Sponsor

University of Giessen

Enrollment

110 participants

Start Date

Aug 25, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for macular edema caused by central retinal vein occlusion (CRVO) — a condition where a vein in the retina becomes blocked, causing fluid to build up in the central part of the eye (the macula) and blurring vision. The treatment being studied combines ranibizumab (an anti-VEGF injection that reduces fluid) with targeted laser treatment to damaged areas of the retina. Researchers want to see if this combined approach is better than using the injection alone, potentially reducing how many injections patients need over time while preserving or improving vision. You may be eligible if: - You are over 18 years old - You have macular edema due to central retinal vein occlusion (CRVO) diagnosed within the last 6 months - Your retinal thickness (foveal) exceeds 250 micrometers on OCT imaging - Your vision in the affected eye falls within a certain range (24–78 letters on the ETDRS chart) - You have significant areas of poor blood flow in the peripheral retina You may NOT be eligible if: - Your CRVO has caused damage to the central blood vessel network of the macula (ischemic maculopathy) - Your macular edema has another cause (e.g., diabetes, uveitis, macular degeneration) - You have previously used anti-VEGF injections in the study eye - You have had eye surgery, laser treatment, or steroid injections in the study eye recently - You have had a stroke or heart attack in the past 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRanibizumab Injection

initial three injections of Ranibizumab - afterwards pro re nata monthly

DEVICELaser photocoagulation

Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times


Locations(15)

Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie

Innsbruck, Austria

Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde

Dresden, Germany

Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie

Düsseldorf, Germany

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

Marburg, Germany

Ludwig-Maximilians-Universität München, Augenklinik

München, Germany

Augenzentrum am St. Franziskus-Hospital Münster

Münster, Germany

Universitätsklinikum Klinik für Augenheilkunde

Münster, Germany

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, Germany

Universitätsklinikum Ulm, Klinik für Augenheilkunde

Ulm, Germany

Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde

Zschopau, Germany

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NCT04444492