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Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START

NCT ID: NCT02246829

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.

The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed

Conditions

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Neovascular Age-related Macular Degeneration of All Subtypes

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aflibercept 2mg Intravitreal injection

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

Group Type OTHER

Intravitreal injection

Intervention Type PROCEDURE

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

Interventions

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Intravitreal injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François KOROBELNIK, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Geneviève CHENE, MDPhD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Locations

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

Créteil, , France

Site Status

Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

Dijon, , France

Site Status

Service d'Ophtalmologie Hôpital de la croix rousse

Lyon, , France

Site Status

Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

Montargis, , France

Site Status

Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

Nantes, , France

Site Status

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

Paris, , France

Site Status

Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

Paris, , France

Site Status

Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

Paris, , France

Site Status

Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard

Rouen, , France

Site Status

Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 23558214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18088159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17021318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21057805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21640258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33600134 (View on PubMed)

Other Identifiers

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CHUBX 2013/18

Identifier Type: -

Identifier Source: org_study_id