Clinical trial NCT04793100: Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
Official title: Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Retinal Vein Occlusion
Keywords: Central Retinal Vein Occlusion
Spontaneous retinal artery pulsation
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Bayer
First posted: 2021-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs
timeFrame: At inclusion and 12 months after CRVO
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
city: Strasbourg
country: France
facility: Centre médical et chirurgical de la rétine Strasbourg
city: Écully
country: France
facility: Centre Pôle Vision du Val d'ouest, Lyon
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Martine MAUGET FAYSSE, MD
role: PRINCIPAL_INVESTIGATOR
References: