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
  • End date
    May 3, 2024
  • participants needed
    60
  • sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
Updated on 3 November 2021

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.

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 therapeutic management will be standardized by the use of aflibercept for patients requiring intravitreal injection, aflibercept being the most widely referenced treatment currently used in the participating centers.

Details
Condition Central Retinal Vein Occlusion
Treatment Ophthalmologic exam at inclusion and 12 months after CRVO, Treatment standardization with aflibercept
Clinical Study IdentifierNCT04793100
SponsorFondation Ophtalmologique Adolphe de Rothschild
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

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
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