Clinical trial NCT02880644: Ultra-wide Fluorescein Angiography in Patients With Central Retinal Vein Occlusion Treated by Afilbercept
Official title: Ultra-wide Fluorescein angiograpHy to Evaluate the Progression of Retinal ischeMia After aflibErcept Injections in patientS With Central Retinal Vein Occlusion in Real Life (HERMES Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Keywords: Central retinal vein occlusion
OCT-A
CRVO
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Bayer
name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2016-08-26
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with central retinal vein occlusion

Brief summary: In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific.

With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.

Detailed description: The pathophysiology of Central Retinal Vein Occlusion (CRVO) is incompletely understood, but a significant slow-down in blood flow, caused by various predisposing factors, results in the release of VEGF, leading to the breakdown of the blood-retinal-barrier and finally to macular edema. The level of VEGF has been also correlated with neovascularization and vascular permeability in patients with ischemic CRVO. Several treatments have been used to treat patients with CRVO such as hemodilution, surgery, laser treatment and corticoids injection. However anti-vascular endothelial growth factor (anti-VEGF) agents administered by intravitreal injection, improve both visual and anatomic outcomes in patients with macular edema secondary to CRVO. Aflibercept is a fusion protein, use by intravitreal injection. In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific. In these studies, anatomic outcomes such as ischemic progression and retinal perfusion status were evaluated as secondary objectives; the primary objective of these studies was visual outcome.

With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.

Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 years or more
* Patients with a diagnosis of CRVO (presence of retinal hemorrhages associated with vein dilation and tortuosity in the 4 quadrants)
* The decision for treatment with Aflibercept (Eylea®) has been made for patients with a decrease in Best Corrected Visual Acuity (BCVA) and macular edema
* Duration of CRVO not more than 4 months
* Naïve patients. Patient with previous CRVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of CRVO are also considered naive
* Patient who agrees to participate to the study and who has given his/her written, informed consent

Exclusion Criteria:

* Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
* Patient who does not meet the local indication criteria for aflibercept treatment. Contraindications listed in the SmPCs must be taken into account including:
* Hypersensitivity to the active substance aflibercept or to any of the excipients listed in SmPC of the product
* Active or suspected ocular or periocular infection
* Active severe intraocular inflammation
* CRVO complicated with neovascularization of the anterior segment
* Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
* Patient already included in the study for the treatment of the fellow eye
* Pregnant or breastfeeding woman
* Lack of effective contraception for women of childbearing age
* Patient taking part in an interventional study
* Patients not covered by the French Health Insurance

Primary outcomes:
measure: Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in visual acuity from baseline to months 3, 6, 12 and 24
timeFrame: Baseline and 3, 6, 12 and 24 months
measure: Change from baseline in non-perfused areas in both macula and peripheral retina at 3, 6 and 12 months
timeFrame: Baseline and 3, 6 and 12 months
measure: Mean time between the last two injections
timeFrame: Up to 18 weeks
measure: Mean number of injections by patient from baseline to end-of-study visit
timeFrame: From baseline to 24 months
measure: Mean number of visits by patient from baseline to end-of-study visit
timeFrame: From baseline to 24 months
measure: Change from baseline in central retinal thickness at 3, 6, 12 and 24 months
timeFrame: Baseline and 3, 6, 12 and 24 months
measure: Change in vascular density in OCT-A from baseline to months 3, 6, 12, 24
timeFrame: Baseline and 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
city: Marseille
country: France
facility: Centre Monticelli Paradis d'Ophtalmologie
city: Nantes
country: France
facility: Centre Hospitalier Universitaire De Nantes
city: Nice
country: France
facility: CHU Nice-Saint-Roch
city: Paris
country: France
facility: Centre d'exploration ophtalmologique de l'odéon
city: Paris
country: France
facility: Centre d'Imagerie et de laser
city: Paris
country: France
facility: CHNO des Quinze-Vingts
city: Paris
country: France
facility: Hôpital Lariboisière - APHP
city: Reims
country: France
facility: Hôpital Robert Debré - CHU Reims
Study officials:
affiliation: Centre Hospitalier Intercommunal Créteil
name: Agnès GLACET-BERNARD, MD
role: PRINCIPAL_INVESTIGATOR
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