NCT02246829

Brief Summary

Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

September 11, 2014

Last Update Submit

November 18, 2016

Conditions

Neovascular Age-related Macular Degeneration of All Subtypes

Keywords

wet AMD, SD-OCT, intravitreal injection, central retinal thickness,

Outcome Measures

Primary Outcomes (1)

  • Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

    12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

Secondary Outcomes (6)

  • Time to get a dry SD-OCT after initiation of a treatment by Aflibercept

    Every 2 weeks from treatment initiation (inclusion) to week 12

  • Evolution of morphological and visual modification under Aflibercept (EYLEA®)

    Every 2 weeks from treatment initiation (inclusion) to week 12

  • Occurence of pigment epithelial detachment

    Every 2 weeks from treatment initiation (inclusion) to week 12

  • Evolution of retinal hemorrhage if any

    Every 2 weeks from treatment initiation (inclusion) to week 12

  • Evolution in the atrophic lesions

    Every 2 weeks from treatment initiation (inclusion) to week 12

  • +1 more secondary outcomes

Study Arms (1)

Aflibercept 2mg Intravitreal injection

OTHER

2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period

Procedure: Intravitreal injection

Interventions

Intravitreal injectionPROCEDURE

2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period

Aflibercept 2mg Intravitreal injection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥ 50 years of age
  • Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affects the fovea as evidenced by FA in the study eye
  • Signed Informed Consent
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

You may not qualify if:

  • Prior treatment with anti-VEGF therapy in the study eye
  • Active or suspected ocular or periocular infection.
  • Active severe intraocular inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun

Créteil, 94000, France

Location

Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

Dijon, 21079, France

Location

Service d'Ophtalmologie Hôpital de la croix rousse

Lyon, 69317, France

Location

Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

Montargis, 45200, France

Location

Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

Nantes, 44093, France

Location

Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle

Paris, 75011, France

Location

Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

Paris, 75019, France

Location

Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

Paris, 75475, France

Location

Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard

Rouen, 76100, France

Location

Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

Tours, 37000, France

Location

Related Publications (6)

  • Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.

    PMID: 23558214BACKGROUND

  • Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006.

    PMID: 18088159BACKGROUND

  • Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

    PMID: 17021318BACKGROUND

  • Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.

    PMID: 21057805BACKGROUND

  • Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020.

    PMID: 21640258BACKGROUND

  • Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faysse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

    PMID: 33600134DERIVED

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Jean-François KOROBELNIK, Professor

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, MDPhD

    University Hospital Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 23, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

FR(10)