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

Inclusion Criteria7

  • 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 Criteria18

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04444492