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

NCT04793100 | Completed

• 1 other identifier: MMT_2020_33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Central Retinal Vein Occlusion

Keywords

Central Retinal Vein Occlusion; Spontaneous retinal artery pulsation

Outcome Measures

Primary Outcomes (1)

• Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs

  Evolution of best corrected visual acuity on ETDRS scale (Early treatment diabetic retinopathy study scale) in letters read and validated Infrared movies will be made at inclusion from the Heidelberg Spectralis device. Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic disc site in the form of pulse-dependent beats of the arterial walls. For each movie each ophthalmologist will give his assessment: SPARs+ or SPARs-. In case of discrepancy, a third ophthalmological opinion will be requested.

  At inclusion and 12 months after CRVO

Study Arms (1)

Follow-up for 1 year

EXPERIMENTAL

Other: Ophthalmologic exam at inclusion and 12 months after CRVO; Drug: Treatment standardization with aflibercept

Interventions

Ophthalmologic exam at inclusion and 12 months after CRVO 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.

Follow-up for 1 year

Treatment standardization with aflibercept DRUG

For patients requiring intravitreal injection

Follow-up for 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CRVO, with or without macular edema.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Bayer: collaborator

Study Sites (3)

Centre Pôle Vision du Val d'ouest, Lyon

Écully, 69130, France

Location

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

Centre médical et chirurgical de la rétine Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martine MAUGET FAYSSE, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: March 24, 2021
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)