Central Retinal Vein OcclusionPULSOVNCT04793100
Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
A study testing Ophthalmologic exam at inclusion and 12 months after CRVO and Treatment standardization with aflibercept in people with Central Retinal Vein Occlusion, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Ophthalmologic exam at inclusion and 12 months after CRVO and Treatment standardization with aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Mar 2021to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Pôle Vision du Val d'ouest, Lyon
Écully, 69130
Hôpital Fondation A. de Rothschuld
Paris, 75019
Centre médical et chirurgical de la rétine Strasbourg
Strasbourg, 67000
About this study
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.
Read the 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
- Being tested
- Ophthalmologic exam at inclusion and 12 months after CRVO, Treatment standardization with aflibercept
- Keywords
- Central Retinal Vein Occlusion, Spontaneous retinal artery pulsation
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic exam at inclusion and 12 months after CRVOOther
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 afliberceptDrug
For patients requiring intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Follow-up for 1 year | Experimental | Not described Receives: Other: Ophthalmologic exam at inclusion and 12 months after CRVO; Drug: Treatment standardization with aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion and 12 months after CRVO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start24 Mar 2021
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793100
- Sponsor's protocol ID
- MMT_2020_33
- Acronym
- PULSOV
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04793100
- Acronym / sponsor ID
- PULSOV / MMT_2020_33
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- Central Retinal Vein Occlusion, Spontaneous retinal artery pulsation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Bayer
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up for 1 year | Experimental | Other: Ophthalmologic exam at inclusion and 12 months after CRVO, Drug: Treatment standardization with aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmologic exam at inclusion and 12 months after CRVOAs 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. | Other | Follow-up for 1 year |
| Treatment standardization with afliberceptFor patients requiring intravitreal injection | Drug | Follow-up for 1 year |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine MAUGET FAYSSE, MD principal investigator
Hôpital Fondation A. de Rothschild
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmologic exam at inclusion and 12 months after CRVO and Treatment standardization with aflibercept in people with Central Retinal Vein Occlusion, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.