Spontaneous retinal artery pulses as a prognostic determinant of central retinal vein occlusions in patients with and without intravitreal aflibercept injections

Phase 1

• Conditions: Central retinal vein occlusions; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-005449-18-FR
• Lead Sponsor: Hôpital Fondation A. de Rothschild / Service de recherche clinique

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patient over 18 years of age
- Diagnosis of OVCR, with or without macular edema.
- Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
- Naive intravitreal injection and intravitreal corticosteroid implant
- Affiliate or beneficiary of a Health Insurance plan
- Having received informed information about the study and having signed a consent to participate in the study
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Patient benefiting from a legal protection measure
- 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 OVCR
- Active or suspected ocular or periocular infection
- Severe intraocular inflammation
- Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified