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

April 28, 2025 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation A. de Rothschuld
      • Strasbourg, France, 67000
        • Centre médical et chirurgical de la rétine Strasbourg
      • Écully, France, 69130
        • Centre Pôle Vision du Val d'ouest, Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follow-up for 1 year
Other: 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.
Drug: Treatment standardization with aflibercept
For patients requiring intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs
Time Frame: At inclusion and 12 months after CRVO
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Bayer

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, MD, Hôpital Fondation A. de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

March 17, 2025

Study Completion (Actual)

March 17, 2025

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMT_2020_33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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