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Trial record 38 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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ClinicalTrials.gov Identifier: NCT02880644
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

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.


Condition or disease
Retinal Vein Occlusion

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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)
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020



Primary Outcome Measures :
  1. Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Change in visual acuity from baseline to months 3, 6, 12 and 24 [ Time Frame: Baseline and 3, 6, 12 and 24 months ]
  2. 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 ]
  3. Mean time between the last two injections [ Time Frame: Up to 18 weeks ]
  4. Mean number of injections by patient from baseline to end-of-study visit [ Time Frame: From baseline to 24 months ]
  5. Mean number of visits by patient from baseline to end-of-study visit [ Time Frame: From baseline to 24 months ]
  6. Change from baseline in central retinal thickness at 3, 6, 12 and 24 months [ Time Frame: Baseline and 3, 6, 12 and 24 months ]
  7. 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 ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with central retinal vein occlusion
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880644


Contacts
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Contact: Agnès GLACET-BERNARD, MD +331 45 17 52 21 agnes.glacet@chicreteil.fr
Contact: Amelle ISSA +331 57 02 26 32 amelle.issa@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal Créteil Recruiting
Créteil, France
Contact: Agnès Glacet-Bernard, MD       agnes.glacet@chicreteil.fr   
Centre Monticelli Paradis d'Ophtalmologie Recruiting
Marseille, France
Contact: Christophe Morel, MD       cvmorel@orange.fr   
Centre Hospitalier Universitaire De Nantes Not yet recruiting
Nantes, France, 44093
Contact: Michel Weber, MD PhD       michel.weber@chu-nantes.fr   
Principal Investigator: Michel Weber, MD PhD         
Sub-Investigator: Hélène Masse, MD         
Sub-Investigator: Chloé Couret, MD         
Sub-Investigator: Guylène Le Meur, MD         
Sub-Investigator: Alexandre Bonissent, MD         
Sub-Investigator: Clémence Carbonniere, MD         
CHU Nice-Saint-Roch Recruiting
Nice, France
Contact: Stéphanie Baillif, MD PhD       baillif.s@chu-nice.fr   
Centre d'exploration ophtalmologique de l'odéon Recruiting
Paris, France
Contact: Florence Coscas, MD       coscas.f@gmail.com   
Centre d'Imagerie et de laser Recruiting
Paris, France
Contact: Sylvia Nghiem Buffet, MD       buffet.nghiem@free.fr   
CHNO des Quinze-Vingts Not yet recruiting
Paris, France
Contact: Jean-François Girmens, MD       jfgirmens@quinze-vingts.fr   
Hôpital Lariboisière - APHP Not yet recruiting
Paris, France
Contact: Ramin Tadayoni, MD PhD       ramin.tadayoni@aphp.fr   
Contact: Ali Erginay, MD       ali.erginay@aphp.fr   
Sub-Investigator: Ali Erginay, MD         
Hôpital Robert Debré - CHU Reims Recruiting
Reims, France
Contact: Carl Arndt, MD PhD       carl.arndt@orange.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Bayer
Investigators
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Principal Investigator: Agnès GLACET-BERNARD, MD Centre Hospitalier Intercommunal Créteil

Additional Information:

Publications:

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Responsible Party: Agnes Glacet-Bernard, Ophtalmologist, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02880644     History of Changes
Other Study ID Numbers: HERMES
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil:
Central retinal vein occlusion
OCT-A
CRVO

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases