Combination of Ranibizumab and Targeted Laser Photocoagulation (NCT04444492) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Combination of Ranibizumab and Targeted Laser Photocoagulation
Austria, Germany88 participantsStarted 2020-08-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
What they're measuring
1
Efficacy endpoint is the time to treatment success