Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
NCT04793100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-04-30
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.
Conditions
- Central Retinal Vein Occlusion
Interventions
- 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
Sponsors & Collaborators
- collaborator INDUSTRY
-
Fondation Ophtalmologique Adolphe de Rothschild
lead NETWORK
Principal Investigators
-
Martine MAUGET FAYSSE, MD · Hôpital Fondation A. de Rothschild
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-24
- Primary Completion
- 2025-03-17
- Completion
- 2025-03-17
Countries
- France
Study Locations
More Related Trials
-
Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
NCT02957760 ·Status: UNKNOWN ·Phase: PHASE2
-
Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
NCT02956330 ·Status: COMPLETED
-
Phase I RVC With Ocriplasmin for CRVO
NCT02747030 ·Status: COMPLETED ·Phase: PHASE1
-
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
NCT00943072 ·Status: COMPLETED ·Phase: PHASE3
-
Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
NCT04707625 ·Status: TERMINATED ·Phase: PHASE4
-
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
NCT02033018 ·Status: UNKNOWN ·Phase: PHASE4
-
Surgical Stabilizer Assisted RVC With rtPA for CRVO
NCT03417401 ·Status: WITHDRAWN ·Phase: PHASE1
-
Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion
NCT02645747 ·Status: COMPLETED
-
Central Vein Occlusion Study (CVOS)
NCT00000131 ·Status: COMPLETED ·Phase: PHASE3
-
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)
NCT02040220 ·Status: COMPLETED
-
Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept
NCT04287348 ·Status: TERMINATED ·Phase: PHASE4
-
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
NCT00970957 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients
NCT02257502 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR
NCT05660447 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion
NCT02033031 ·Status: COMPLETED ·Phase: PHASE3
-
The Effectiveness of Intravitreal Avastin Injection for CRVO
NCT01678248 ·Status: UNKNOWN
-
Bevacizumab and Retinal Vascular Occlusions
NCT00347711 ·Status: WITHDRAWN ·Phase: PHASE3
-
Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
NCT05514925 ·Status: UNKNOWN ·Phase: PHASE4
-
Real Life Study in Myopic Neovascularization
NCT03797547 ·Status: UNKNOWN
-
Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy
NCT00418431 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
NCT01950741 ·Status: COMPLETED ·Phase: PHASE4
-
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
NCT01053858 ·Status: COMPLETED ·Phase: NA
-
Combined Triple Procedure in Retinal Vein Occlusion (RVO)
NCT00805064 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Intravitreal Bevacizumab in Eyes With Choroidal Neovascularization Secondary to Angioid Streaks
NCT00599820 ·Status: TERMINATED ·Phase: PHASE3
-
Biomarkers and Choroidal Neovascularization
NCT04439708 ·Status: ACTIVE_NOT_RECRUITING