AzTrials
AzTrials

Retinal Vein OcclusionHERMESNCT02880644

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

An observational study of Retinal Vein Occlusion, run by Centre Hospitalier Intercommunal Creteil at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Retinal Vein Occlusion
How many people
65 participants
Where
9 sitesFrance
Study dates
26 Jan 2017to 30 Nov 2022
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with central retinal vein occlusion

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Centre Hospitalier Intercommunal Créteil

    Créteil

  • Centre Monticelli Paradis d'Ophtalmologie

    Marseille

  • Centre Hospitalier Universitaire De Nantes

    Nantes, 44093

  • CHU Nice-Saint-Roch

    Nice

  • Centre d'exploration ophtalmologique de l'odéon

    Paris

  • Centre d'Imagerie et de laser

    Paris

  • CHNO des Quinze-Vingts

    Paris

  • Hôpital Lariboisière - APHP

    Paris

  • Hôpital Robert Debré - CHU Reims

    Reims

Other trials in France

About this study

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)

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.

Read the 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.

Keywords
Central retinal vein occlusion, OCT-A, CRVO
Medical subject headings
Retinal Vein Occlusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and 12 months

Secondary outcomes (7)

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

    Measured: 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

    Measured: Baseline and 3, 6 and 12 months

  3. Mean time between the last two injections

    Measured: Up to 18 weeks

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

    Measured: From baseline to 24 months

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

    Measured: From baseline to 24 months

  6. Change from baseline in central retinal thickness at 3, 6, 12 and 24 months

    Measured: Baseline and 3, 6, 12 and 24 months

  7. Change in vascular density in OCT-A from baseline to months 3, 6, 12, 24

    Measured: Baseline and 3, 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start26 Jan 2017
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
65 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880644
Sponsor's protocol ID
HERMES
Acronym
HERMES
Status last verified
Jun 2023
First submitted
23 Aug 2016
Last updated
29 Jun 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 9349161

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

    PubMed 1250571

  • 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.

    PubMed 23901258

  • 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.

    PubMed 16133018

  • 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.

    PubMed 9109757

  • 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.

    PubMed 9097788

  • 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.

    PubMed 16508430

  • 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.

    PubMed 20953877

  • 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.

    PubMed 19752419

  • 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.

    PubMed 20417567

  • 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.

    PubMed 21715011

  • 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.

    PubMed 24679444

  • 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.

    PubMed 25068637

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Vein Occlusion, run by Centre Hospitalier Intercommunal Creteil at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880644, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in