Ultra-wide Fluorescein Angiography in Patients With Central Retinal Vein Occlusion Treated by Afilbercept (HERMES)

June 27, 2023 updated by: Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

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)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Centre Hospitalier Intercommunal Créteil
      • Marseille, France
        • Centre Monticelli Paradis d'Ophtalmologie
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes
      • Nice, France
        • CHU Nice-Saint-Roch
      • Paris, France
        • Hôpital Lariboisière - APHP
      • Paris, France
        • Centre D'exploration Ophtalmologique De L'odéon
      • Paris, France
        • Centre d'Imagerie et de laser
      • Paris, France
        • CHNO des Quinze-Vingts
      • Reims, France
        • Hôpital Robert Debré - CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with central retinal vein occlusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months
Time Frame: Baseline and 12 months
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in visual acuity from baseline to months 3, 6, 12 and 24
Time Frame: Baseline and 3, 6, 12 and 24 months
Baseline and 3, 6, 12 and 24 months
Change from baseline in non-perfused areas in both macula and peripheral retina at 3, 6 and 12 months
Time Frame: Baseline and 3, 6 and 12 months
Baseline and 3, 6 and 12 months
Mean time between the last two injections
Time Frame: Up to 18 weeks
Up to 18 weeks
Mean number of injections by patient from baseline to end-of-study visit
Time Frame: From baseline to 24 months
From baseline to 24 months
Mean number of visits by patient from baseline to end-of-study visit
Time Frame: From baseline to 24 months
From baseline to 24 months
Change from baseline in central retinal thickness at 3, 6, 12 and 24 months
Time Frame: Baseline and 3, 6, 12 and 24 months
Baseline and 3, 6, 12 and 24 months
Change in vascular density in OCT-A from baseline to months 3, 6, 12, 24
Time Frame: Baseline and 3, 6, 12 and 24 months
Baseline and 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Bayer
Association Clinique Thérapeutique Infantile du val de Marne

Investigators

  • Principal Investigator: Agnès GLACET-BERNARD, MD, Centre Hospitalier Intercommunal Créteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2017

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimated)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERMES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Vein Occlusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe