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).
Aged
Angiogenesis Inhibitors
/ administration & dosage
Female
Follow-Up Studies
France
/ epidemiology
Humans
Incidence
Intravitreal Injections
Male
Prospective Studies
Receptors, Vascular Endothelial Growth Factor
/ administration & dosage
Recombinant Fusion Proteins
/ administration & dosage
Retinal Pigment Epithelium
/ diagnostic imaging
Time Factors
Tomography, Optical Coherence
/ methods
Treatment Outcome
Vascular Endothelial Growth Factor A
/ antagonists & inhibitors
Visual Acuity
/ physiology
Wet Macular Degeneration
/ diagnosis
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
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
588-594Références
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.