Clinical trial NCT02246829: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START
Official title: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration of All Subtypes
Keywords: wet AMD, SD-OCT, intravitreal injection, central retinal thickness,
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
timeFrame: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
Secondary outcomes:
measure: Time to get a dry SD-OCT after initiation of a treatment by Aflibercept
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution of morphological and visual modification under Aflibercept (EYLEA®)
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Occurence of pigment epithelial detachment
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution of retinal hemorrhage if any
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Evolution in the atrophic lesions
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
measure: Occurence the central Retinal Thickness
timeFrame: Every 2 weeks from treatment initiation (inclusion) to week 12
Other outcomes:
Locations:
city: Creteil
country: France
facility: Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun
city: Dijon
country: France
facility: Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908
city: Lyon
country: France
facility: Service d'Ophtalmologie Hôpital de la croix rousse
city: Montargis
country: France
facility: Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve
city: Nantes
country: France
facility: Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau
city: Paris
country: France
facility: Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle
city: Paris
country: France
facility: Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin
city: Paris
country: France
facility: Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré
city: Rouen
country: France
facility: Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard
city: Tours
country: France
facility: Centre Ophtalmologie Transparence 30 Boulevard Heurteloup
Study officials:
affiliation: University Hospital Bordeaux, France
name: Jean-François KOROBELNIK, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Geneviève CHENE, MDPhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.