Spontaneous retinal artery pulses as a prognostic determinant of central retinal vein occlusions in patients with and without intravitreal aflibercept injections

Spontaneous retinal artery pulses as a prognostic determinant of central retinal vein occlusions in patients with and without intravitreal aflibercept injections. - PULSOV

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005449-18-FR

Enrollment

Registered

2020-12-10

Start date

2021-03-08

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central retinal vein occlusions

Interventions

Trade Name: Eylea 40 mg/mL, solution injectable en seringue préremplie Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient over 18 years of age - Diagnosis of OVCR, with or without macular edema. - Onset of symptoms in the previous month (maximum 30 days prior to inclusion) - Naive intravitreal injection and intravitreal corticosteroid implant - Affiliate or beneficiary of a Health Insurance plan - Having received informed information about the study and having signed a consent to participate in the study - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Patient benefiting from a legal protection measure - 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 OVCR - Active or suspected ocular or periocular infection - Severe intraocular inflammation - Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Comparison between PARS+ and PARS- patients at inclusion : 1. Percentages of patients with macular edema during the first year of follow-up; 2. changes in macular thickness between diagnosis and visit at 1 year; 3. Percentages of occurrence of OVCR-related complications during the first year of follow-up (neovascular glaucoma or intravitreal hemorrhage); 4. Number of aflibercept injections during the first year of follow-up (only for patients treated with aflibercept); 5. Mean time between the last 2 aflibercept injections (only for patients treated with aflibercept). Exploratory analysis of various parameters measured by Colour Doppler Ultrasound of the orbit and optic nerve at the acute phase of OVCR and at 1 year, including subgroup analyses based on the presence or absence of PARS at baseline, for patients managed at the A. de Rothschild Foundation Hospital.;Primary end point(s): The evolution of visual acuity (BCVA on ETDRS scale) in letters read and validated between the beginning of the treatment and 1 year. Infrared films will be made at inclusion from the Heidelberg Spectralis device (Heidelberg Engineering Germany). Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic papilla in the form of pulse-dependent beats of the arterial walls. For each film each ophthalmologist will give his assessment: PARS+ or PARS-. In case of discrepancy, a third ophthalmological opinion will be requested. ;Main Objective: To compare the evolution of visual acuity between inclusion and visit at one year in patients with retinal central vein occlusion with retinal central artery pulsating versus without retinal central artery pulsating ;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Secondary Objective: Comparison between PARS+ and PARS- patients at inclusion : 1. Percentages of patients with macular edema during the first year of follow-up; 2. changes in macular thickness between diagnosis and visit at 1 year; 3. Percentages of occurrence of OVCR-related complications during the first year of follow-up (neovascular glaucoma or intravitreal hemorrhage); 4. Number of aflibercept injections during the first year of follow-up (only for patients treated with aflibercept); 5. Mean time between the last 2 aflibercept injections (only for patients treated with aflibercept). Exploratory analysis of various parameters measured by Colour Doppler Ultrasound of the orbit and optic nerve at the acute phase of OVCR and at 1 year, including subgroup analyses based on the presence or absence of PARS at baseline, for patients managed at the A. de Rothschild Foundation Hospital.;Primary end point(s): The evolution of visual acuity (BCVA on ETDRS scale) in letters read and validated between the beginning of the treatment and 1 year. Infrared films will be made at inclusion from the Heidelberg Spectralis device (Heidelberg Engineering Germany). Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic papilla in the form of pulse-dependent beats of the arterial walls. For each film each ophthalmologist will give his assessment: PARS+ or PARS-. In case of discrepancy, a third ophthalmological opinion will be requested. ;Main Objective: To compare the evolution of visual acuity between inclusion and visit at one year in patients with retinal central vein occlusion with retinal central artery pulsating versus without retinal central artery pulsating ;Timepoint(s) of evaluation of this end point: 1 year

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Secondary

Measure	Time frame
Secondary end point(s): 1. Macular edema will be determined by the ophthalmologist based on the OCT examination ; 2. The measurement of macular thickness in µm will be carried out using a measurement software integrated in the OCT 3. Complications of OVCR will be collected at one year from the patient's chart; 4. The number of injections of aflibercept during the first year of follow-up will be collected at one year from the patient's chart ; 5. The time between the last 2 injections of aflibercept will be collected at one year from the patient's chart.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Secondary end point(s): 1. Macular edema will be determined by the ophthalmologist based on the OCT examination ; 2. The measurement of macular thickness in µm will be carried out using a measurement software integrated in the OCT 3. Complications of OVCR will be collected at one year from the patient's chart; 4. The number of injections of aflibercept during the first year of follow-up will be collected at one year from the patient's chart ; 5. The time between the last 2 injections of aflibercept will be collected at one year from the patient's chart.;Timepoint(s) of evaluation of this end point: 1 year

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Countries

France

Contacts

Public ContactAdministrative Coordinator

Hôpital Fondation A. de Rothschild / Service de recherche clinique

pvachey@for.paris+33148036433

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026