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

Central Retinal Vein Occlusion Clinical Trial

— PULSOV  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04793100
• Other study ID #: MMT_2020_33
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: March 23, 2025

Study information

• Verified date: March 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 23, 2025
• Est. primary completion date: March 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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