Status:
RECRUITING
Combination of Ranibizumab and Targeted Laser Photocoagulation
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
University of Leipzig
Conditions:
Central Retinal Vein Occlusion With Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 peripher...
Detailed Description
Retinal vein occlusion (RVO) is the second most common retinal vascular disease leading to visual impairment. Main cause for visual impairment in CRVO (Central Retinal Vein Occlusion) is macular edema...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04444492
Start Date
August 25 2020
End Date
November 30 2027
Last Update
March 26 2025
Active Locations (15)
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1
Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie
Innsbruck, Austria, 6020
2
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde
Dresden, Germany, 01307
3
Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie
Düsseldorf, Germany
4
Universitätsklinikum Klinik für Augenheilkunde Freiburg
Freiburg im Breisgau, Germany, 79106