Laser combo may cut eye injection burden for vein blockage patients
NCT ID NCT04444492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding targeted laser treatment to the standard ranibizumab injections can help people with macular edema (swelling) from a central retinal vein occlusion need fewer injections over time. About 88 adults with this condition will receive either injections alone or injections plus laser. The goal is to see if the combination leads to a longer treatment-free period and fewer total injections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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88 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde
Zschopau, Germany
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Augenzentrum am St. Franziskus-Hospital Münster
Münster, 48145, Germany
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Hannover MHH Universitätsklinik für Augenheilkunde
Hanover, 30625, Germany
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Klinikum der Stadt Ludwigshafen Augenklinik
Ludwigshafen, 67063, Germany
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Ludwig-Maximilians-Universität München, Augenklinik
München, Germany
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Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie
Innsbruck, 6020, Austria
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University Hospital of Leipzig Department of Ophthalmology
Leipzig, 04103, Germany
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Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde
Marburg, 35043, Germany
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Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde
Giessen, Germany
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Universitätsklinikum Klinik für Augenheilkunde Freiburg
Freiburg im Breisgau, 79106, Germany
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Universitätsklinikum Tübingen, Department für Augenheilkunde
Tübingen, Germany
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Universitätsklinikum Ulm, Klinik für Augenheilkunde
Ulm, Germany
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