Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections (PULSOV)
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| ClinicalTrials.gov Identifier: NCT04793100 |
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Recruitment Status :
Recruiting
First Posted : March 11, 2021
Last Update Posted : October 27, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Central Retinal Vein Occlusion | Other: Ophthalmologic exam at inclusion and 12 months after CRVO Drug: Treatment standardization with aflibercept | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | March 24, 2021 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | May 2024 |
| 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 :
Drug: Treatment standardization with aflibercept For patients requiring intravitreal injection |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793100
| Contact: Amélie YAVCHITZ, MD | +33148036433 | ayavchitz@for.paris | |
| Contact: Martine MAUGET FAYSSE, MD | +33148036437 | mmfaysse@for.paris |
| France | |
| Hôpital Fondation A. de Rothschuld | Recruiting |
| Paris, France, 75019 | |
| Contact: Martine MAUGET FAYSSE, MD +33148036437 mmfaysse@for.paris | |
| Contact: Vivien VASSEUR +33148036440 vvasseur@for.paris | |
| Centre médical et chirurgical de la rétine Strasbourg | Recruiting |
| Strasbourg, France, 67000 | |
| Contact: Benjamin WOLFF, MD | |
| Centre Pôle Vision du Val d'ouest, Lyon | Recruiting |
| Écully, France, 69130 | |
| Principal Investigator: | Martine MAUGET FAYSSE, MD | Hôpital Fondation A. de Rothschild |
| Responsible Party: | Fondation Ophtalmologique Adolphe de Rothschild |
| ClinicalTrials.gov Identifier: | NCT04793100 |
| Other Study ID Numbers: |
MMT_2020_33 |
| First Posted: | March 11, 2021 Key Record Dates |
| Last Update Posted: | October 27, 2021 |
| Last Verified: | October 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Central Retinal Vein Occlusion Spontaneous retinal artery pulsation |
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Retinal Vein Occlusion Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Aflibercept Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |