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

NCT ID: NCT04793100

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2025-03-17

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.

Conditions

Central Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Follow-up for 1 year

Group Type: EXPERIMENTAL

Ophthalmologic exam at inclusion and 12 months after CRVO

Intervention Type: OTHER

As part of routine care : OCT-B (Optical coherence tomography-B), OCT-angiography (Optical coherence tomography and fluorescein angiography after pupillary dilatation (at inclusion only)

Added by the study :

• Assessment of best corrected visual acuity in letters read and validated using the ETDRS scale ;
• The shooting of a 10 second infrared movie by the Heidelberg Spectralis device centered on the head of the optic nerve (at inclusion only)
• A measurement of the eye tension with an air tonometer (at inclusion only)
• A blood pressure measurement (diastolic and systolic) and pulse measurement (at inclusion only)
• A color retinophotography (Optos) with autofluorescence images
• A color Doppler ultrasound of the optic nerve of both eyes will be performed, for patients treated at the Foundation A de Rothschild Hospital only.

Treatment standardization with aflibercept

Intervention Type: DRUG

For patients requiring intravitreal injection

Interventions

Ophthalmologic exam at inclusion and 12 months after CRVO

As part of routine care : OCT-B (Optical coherence tomography-B), OCT-angiography (Optical coherence tomography and fluorescein angiography after pupillary dilatation (at inclusion only)

Added by the study :

• Assessment of best corrected visual acuity in letters read and validated using the ETDRS scale ;
• The shooting of a 10 second infrared movie by the Heidelberg Spectralis device centered on the head of the optic nerve (at inclusion only)
• A measurement of the eye tension with an air tonometer (at inclusion only)
• A blood pressure measurement (diastolic and systolic) and pulse measurement (at inclusion only)
• A color retinophotography (Optos) with autofluorescence images
• A color Doppler ultrasound of the optic nerve of both eyes will be performed, for patients treated at the Foundation A de Rothschild Hospital only.

Intervention Type: OTHER

Treatment standardization with aflibercept

For patients requiring intravitreal injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine MAUGET FAYSSE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation A. de Rothschild

Locations

Centre Pôle Vision du Val d'ouest, Lyon

Écully, , France

Hôpital Fondation A. de Rothschuld

Paris, , France

Centre médical et chirurgical de la rétine Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

MMT_2020_33

Identifier Type: -

Identifier Source: org_study_id