Status:
COMPLETED
Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Bayer
Conditions:
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemor...
Detailed Description
In order to be able to interpret the results on a homogeneous population, given that several molecules have marketing authorization for the management of macular edema following a CRVO, the therapeuti...
Eligibility Criteria
Inclusion
- Diagnosis of CRVO, with or without macular edema.
- Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
- Naive of intravitreal injection and intravitreal corticosteroid implant
- If woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept
Exclusion
- Pregnant or breastfeeding woman
- History of stroke or myocardial infarction in the last 3 months
- Retinal detachment or untreated retinal dehiscence
- Opacity of ocular media
- Amblyopia
- Diabetic retinopathy
- Macular edema of a different etiology than CRVO
- Active or suspected ocular or periocular infection
- Severe intraocular inflammation
- Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04793100
Start Date
March 24 2021
End Date
March 17 2025
Last Update
April 30 2025
Active Locations (3)
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1
Centre Pôle Vision du Val d'ouest, Lyon
Écully, France, 69130
2
Hôpital Fondation A. de Rothschuld
Paris, France, 75019
3
Centre médical et chirurgical de la rétine Strasbourg
Strasbourg, France, 67000