Combining Ranibizumab with Laser Treatment for Eye Condition

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

This study is testing whether combining a common eye injection with laser treatment can help people with a specific eye condition see better and need fewer treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Giessen (other)
• Drugs / interventions: ranibizumab
• Locations: 15 sites (Innsbruck and 14 other locations)
• Trial ID: NCT04444492 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining intravitreal injections of Ranibizumab with targeted laser photocoagulation in patients suffering from central retinal vein occlusion with macular edema. The experimental group will receive additional laser treatments aimed at areas of capillary non-perfusion, potentially reducing the need for repeated injections. The study aims to improve patient outcomes by decreasing treatment frequency and burden associated with ongoing care for this condition. Participants will be monitored over a year to assess the impact of this combined approach on visual acuity and overall eye health.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with macular edema due to central retinal vein occlusion and specific visual acuity scores.

Not a fit: Patients with ischemic maculopathy or macular edema from other causes will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the number of treatments required for patients, improving their quality of life.

How similar studies have performed: Previous studies have shown promise with anti-VEGF treatments, but this specific combination approach is novel.

Eligibility criteria

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.

Where this trial is running

Innsbruck and 14 other locations

• Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie — Innsbruck, Austria (NOT_YET_RECRUITING)
• Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde — Dresden, Germany (WITHDRAWN)
• Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie — Düsseldorf, Germany (WITHDRAWN)
• Universitätsklinikum Klinik für Augenheilkunde Freiburg — Freiburg, Germany (RECRUITING)
• Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde — Gießen, Germany (RECRUITING)
• Hannover MHH Universitätsklinik für Augenheilkunde — Hannover, Germany (RECRUITING)
• University Hospital of Leipzig Department of Ophthalmology — Leipzig, Germany (RECRUITING)
• Klinikum der Stadt Ludwigshafen Augenklinik — Ludwigshafen, Germany (RECRUITING)
• Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde — Marburg, Germany (RECRUITING)
• Ludwig-Maximilians-Universität München, Augenklinik — München, Germany (RECRUITING)
• Augenzentrum am St. Franziskus-Hospital Münster — Münster, Germany (RECRUITING)
• Universitätsklinikum Klinik für Augenheilkunde — Münster, Germany (WITHDRAWN)
• Universitätsklinikum Tübingen, Department für Augenheilkunde — Tübingen, Germany (RECRUITING)
• Universitätsklinikum Ulm, Klinik für Augenheilkunde — Ulm, Germany (RECRUITING)
• Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde — Zschopau, Germany (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Matus Rehak, Professor

Conditions: Central Retinal Vein Occlusion With Macular Edema, retinal vein occlusion