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

NCT02880644 | Completed DMC

• 1 other identifier: HERMES
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 9

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.

Conditions

Retinal Vein Occlusion

Keywords

Central retinal vein occlusion; OCT-A; CRVO

Outcome Measures

Primary Outcomes (1)

• Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months

  Baseline and 12 months

Secondary Outcomes (7)

• Change in visual acuity from baseline to months 3, 6, 12 and 24

  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

  Baseline and 3, 6 and 12 months

• Mean time between the last two injections

  Up to 18 weeks

• Mean number of injections by patient from baseline to end-of-study visit

  From baseline to 24 months

• Mean number of visits by patient from baseline to end-of-study visit

  From baseline to 24 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with central retinal vein occlusion

You may qualify if:

• 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
• Patient who agrees to participate to the study and who has given his/her written, informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Bayer: collaborator
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator

Study Sites (9)

Centre Hospitalier Intercommunal Créteil

Créteil, France

Location

Centre Monticelli Paradis d'Ophtalmologie

Marseille, France

Location

Centre Hospitalier Universitaire De Nantes

Nantes, 44093, France

Location

CHU Nice-Saint-Roch

Nice, France

Location

Centre d'exploration ophtalmologique de l'odéon

Paris, France

Location

Centre d'Imagerie et de laser

Paris, France

Location

CHNO des Quinze-Vingts

Paris, France

Location

Hôpital Lariboisière - APHP

Paris, France

Location

Hôpital Robert Debré - CHU Reims

Reims, France

Location

Related Publications (13)

• Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. doi: 10.1136/bjo.81.8.698. No abstract available.

  PMID: 9349161 BACKGROUND

• Hayreh SS. So-called "central retinal vein occlusion". I. Pathogenesis, terminology, clinical features. Ophthalmologica. 1976;172(1):1-13. doi: 10.1159/000307579.

  PMID: 1250571 BACKGROUND

• Fujikawa M, Sawada O, Miyake T, Kakinoki M, Sawada T, Kawamura H, Ohji M. Correlation between vascular endothelial growth factor and nonperfused areas in macular edema secondary to branch retinal vein occlusion. Clin Ophthalmol. 2013;7:1497-501. doi: 10.2147/OPTH.S46817. Epub 2013 Jul 19.

  PMID: 23901258 BACKGROUND

• Noma H, Minamoto A, Funatsu H, Tsukamoto H, Nakano K, Yamashita H, Mishima HK. Intravitreal levels of vascular endothelial growth factor and interleukin-6 are correlated with macular edema in branch retinal vein occlusion. Graefes Arch Clin Exp Ophthalmol. 2006 Mar;244(3):309-15. doi: 10.1007/s00417-004-1087-4. Epub 2005 Aug 13.

  PMID: 16133018 BACKGROUND

• Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006.

  PMID: 9109757 BACKGROUND

• Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4.

  PMID: 9097788 BACKGROUND

• Opremcak EM, Rehmar AJ, Ridenour CD, Kurz DE. Radial optic neurotomy for central retinal vein occlusion: 117 consecutive cases. Retina. 2006 Mar;26(3):297-305. doi: 10.1097/00006982-200603000-00008.

  PMID: 16508430 BACKGROUND

• Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.

  PMID: 20953877 BACKGROUND

• Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. Arch Ophthalmol. 2009 Sep;127(9):1101-14. doi: 10.1001/archophthalmol.2009.234.

  PMID: 19752419 BACKGROUND

• Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.

  PMID: 20417567 BACKGROUND

• Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29.

  PMID: 21715011 BACKGROUND

• Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27.

  PMID: 24679444 BACKGROUND

• Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.

  PMID: 25068637 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Agnès GLACET-BERNARD, MD

  Centre Hospitalier Intercommunal Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophtalmologist

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: January 26, 2017
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (9)