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).


Journal

Retina (Philadelphia, Pa.)
ISSN: 1539-2864
Titre abrégé: Retina
Pays: United States
ID NLM: 8309919

Informations de publication

Date de publication:
01 Mar 2021
Historique:
pubmed: 19 2 2021
medline: 17 11 2021
entrez: 18 2 2021
Statut: ppublish

Résumé

To assess early changes in spectral-domain optical coherence tomography during the loading phase with intravitreal aflibercept therapy in patients with neovascular age-related macular degeneration. In this prospective, open-label, single-arm, multicenter study, patients with neovascular age-related macular degeneration, who were antivascular endothelial growth factor treatment-naïve, received three monthly initial doses of intravitreal aflibercept 2 mg. The primary outcome was the proportion of patients with dry spectral-domain optical coherence tomography at 12 weeks, defined as an absence of intraretinal edema, intraretinal cysts, subretinal fluid, and subretinal pigment epithelium fluid. Fifty eyes of 50 patients were investigated. At 12 weeks, 34.0% (17/50) had dry spectral-domain optical coherence tomography. Marked reductions were observed for all other spectral-domain optical coherence tomography parameters. The mean macular central thickness fell significantly from 463.2 ± 184.3 µm at baseline to 288.9 ± 76.8 µm at Week 12 (P < 0.0001). The mean best-corrected visual acuity also improved significantly from 61.0 ± 16.0 letters at baseline to 66.6 ± 19.0 letters at Week 12 (P = 0.0006). The anatomic and functional outcomes improved over the 12-week study period. All outcome variables peaked after the third aflibercept injection, confirming the benefit of three initial doses.

Identifiants

pubmed: 33600134
doi: 10.1097/IAE.0000000000002910
pii: 00006982-202103000-00019
doi:

Substances chimiques

Angiogenesis Inhibitors 0
Recombinant Fusion Proteins 0
Vascular Endothelial Growth Factor A 0
aflibercept 15C2VL427D
Receptors, Vascular Endothelial Growth Factor EC 2.7.10.1

Banques de données

ClinicalTrials.gov
['NCT02246829']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

588-594

Références

Jonas JB, Cheung CMG, Panda-Jonas S. Updates on the epidemiology of age-related macular degeneration. Asia Pac J Ophthalmol (Phila) 2017;6:493–497.
Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–16.
Al-Zamil WM, Yassin SA. Recent developments in age-related macular degeneration: a review. Clin Interv Aging 2017;12:1313–1330.
Zhang Y, Chioreso C, Schweizer ML, Abramoff MD. Effects of aflibercept for neovascular age-related macular degeneration: a systematic review and meta-analysis of observational comparative studies. Invest Ophthalmol Vis Sci 2017;58:5616–5627.
Cheung CM, Wong TY. Treatment of age-related macular degeneration. Lancet 2013;382:1230–1232.
Solomon SD, Lindsley K, Vedula SS, et al. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev 2019;3:CD005139.
Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 2012;119:2537–2548.
Ba J, Peng RS, Xu D, et al. Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis. Drug Des Devel Ther 2015;9:5397–5405.
Ebneter A, Gekkiev B, Chanana B, et al. The presence of intra- or subretinal fluid during the loading phase in the treatment of exudative age-related macular degeneration with intravitreal ranibizumab assessed by optical coherence tomography. Ophthalmologica 2015;234:61–66.
Heier JS, Boyer D, Nguyen QD, et al. 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;118:1098–1106.
Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vision Res 2013;90:2–9.
Schmidt-Erfurth U, Waldstein SM. A paradigm shift in imaging biomarkers in neovascular age-related macular degeneration. Prog Retin Eye Res 2016;50:1–24.
Finger RP, Wickremasinghe SS, Baird PN, Guymer RH. Predictors of anti-VEGF treatment response in neovascular age-related macular degeneration. Surv Ophthalmol 2014;59:1–18.
Fung AE, Lalwani GA, Rosenfeld PJ, et al. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol 2007;143:566–583.
Regatieri CV, Branchini L, Duker JS. The role of spectral-domain OCT in the diagnosis and management of neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging 2011;42:S56–6.
Pierro L, Zampedri E, Milani P, et al. Spectral domain OCT versus time domain OCT in the evaluation of macular features related to wet age-related macular degeneration. Clin Ophthalmol 2012;6:219–223.
Ritter M, Simader C, Bolz M, et al. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol 2014;98:1629–1635.
Phadikar P, Saxena S, Ruia S, et al. The potential of spectral domain optical coherence tomography imaging based retinal biomarkers. Int J Retina Vitreous 2017;3:1.
Dervenis N, Younis S. Macular morphology and response to ranibizumab treatment in patients with wet age-related macular degeneration. Clin Ophthalmol 2016;10:1117–1122.

Auteurs

Jean-François Korobelnik (JF)

Service D'Ophtalmologie, Hôpital Pellegrin, CHU de Bordeaux, Bordeaux, France.
Université de Bordeaux, Inserm, Bordeaux Population Health Research Center, Leha team, UMR 1219, Bordeaux, France.

Eric H Souied (EH)

Department of Ophthalmology, Hôpital Intercommunal de Créteil, University Paris Est, Créteil, France.

Hassiba Oubraham (H)

Department of Ophthalmology, Hôpital Intercommunal de Créteil, University Paris Est, Créteil, France.

Sam Razavi (S)

Centre Ophtalmologique Transparence Tours, Tours, France.

Martine Mauget-Faÿsse (M)

Centre D'Investigation Clinique, Rothschild Foundation, Paris, France.

Helene Savel (H)

CHU de Bordeaux, Pôle de santé publique, Unité de soutien méthodologique à la recherche clinique et épidémiologique and CIC 1401-EC, Bordeaux, France ; and.

Genevieve Chene (G)

CHU de Bordeaux, Pôle de santé publique, Unité de soutien méthodologique à la recherche clinique et épidémiologique and CIC 1401-EC, Bordeaux, France ; and.

Sebastian Wolf (S)

Department of Ophthalmology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.

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Classifications MeSH