Overview

Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

Status:
Recruiting

Trial end date:
2024-05-01

Target enrollment:
0

Participant gender:
All

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 hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination. A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed. The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fondation Ophtalmologique Adolphe de Rothschild

Collaborator:

Bayer

Treatments:

Aflibercept

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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