Abstract
Objective
To assess the efficacy of intravitreal aflibercept in treating visual loss and structural
changes in patients with pigment epithelial detachments (PED) secondary to neovascular
age-related macular degeneration (nAMD).
Methods
Prospective, exploratory, open-label study (ClinicalTrials.gov Identifier: NCT02142296).
Participants with PED secondary to nAMD were enrolled and received intravitreal aflibercept
injection on a monthly basis for 3 months, followed by injections on a bimonthly basis
for another 9 months. Best-corrected visual acuity (BCVA), ophthalmic examinations,
optical coherence tomography (OCT) imaging, and fluorescein angiography were performed
based on a predetermined schedule.
Results
Thirty-six participants (37 eyes) were enrolled. At the end of study, 74.3% eyes demonstrated
PED height reduction of 25% or more and 34.3% demonstrated complete resolution. The
average reduction in retinal thickness was 128.4 μm. Participant eyes who had at least
a 25% reduction in PED height at month 4 were labelled as “responders” (73.0%, n = 27),
and those who had less than 25% reduction in PED height were labelled as “partial-responders”
(27.0%, n = 10). Responders demonstrated more significant reduction in PED height
than partial-responders (p <0.0001). The average gain in BCVA was 10.1 Early Treatment Diabetic Retinopathy
Study (ETDRS) letters. Responders demonstrated more gain in BCVA than partial-responders
(p = 0.0018). Among the responders, 57.7% demonstrated disease recurrences with increase
in PED height during bimonthly dosing.
Conclusions
Intravitreal aflibercept injection for patients with PEDs secondary to nAMD has high
response rate with few adverse events. Responders demonstrated BCVA gains, as well
as structural improvements. However, high recurrence rate was found on bimonthly maintenance
dosing.
Résumé
Objectif
Évaluer l'efficacité de l'administration intravitréenne d'aflibercept dans le traitement
de la perte de vision et des modifications structurales imputables aux décollements
de l’épithélium pigmentaire (DÉP) secondaires à la DMLA (dégénérescence maculaire
liée à l’âge) néovasculaire.
Méthodes
Il s'agit d'une étude prospective et exploratoire sans insu (numéro d'identification
sur le site clinicaltrials.gov: NCT02142296). Les participants qui présentaient des
DÉP secondaires à la DMLA néovasculaire ont été admis à l’étude et ont reçu une injection
intravitréenne d'aflibercept une fois par mois pendant 3 mois, suivie d'une injection
tous les 2 mois pendant 9 mois supplémentaires. La meilleure acuité visuelle corrigée
(MAVC), les examens ophtalmologiques, l'imagerie OCT (optical coherence tomography) et l'angiographie fluorescéinique ont été réalisés selon un calendrier préétabli.
Résultats
Ont été admis 36 participants (37 yeux). À la fin de l’étude, 74,3 % des yeux avaient
bénéficié d'une réduction de l’épaisseur des DÉP d'au moins 25 %, tandis que 34,3 %
des yeux ont profité d'une résolution complète du problème. La réduction moyenne de
l’épaisseur rétinienne se chiffrait à 128,4 μm. On a qualifié de « répondants » les
sujets dont les yeux ont manifesté une réduction d'au moins 25 % de l’épaisseur des
DÉP au mois 4 (73,0 %; n = 27); la « réponse partielle » qualifiait les sujets qui
ont bénéficié d'une réduction de moins de 25 % de l’épaisseur des DÉP (27,0 %; n = 10).
Les répondants ont bénéficié d'une réduction plus significative de l’épaisseur des
DÉP que les sujets qui n'ont manifesté qu'une réponse partielle (p < 0,0001). L'amélioration moyenne de la MAVC se chiffrait à 10,1 lettres sur l’échelle
ETDRS (Early Treatment Diabetic Retinopathy Study). L'augmentation de la MAVC des répondants était plus importante que celle des sujets
qui n'ont eu qu'une réponse partielle (p = 0,0018). Parmi les répondants, 57,7 % ont subi des récurrences de leur maladie
se traduisant par un épaississement des DÉP pendant le traitement d'entretien administré
tous les 2 mois.
Conclusions
L'injection intravitréenne d'aflibercept dans le traitement des DÉP secondaires à
la DMLA néovasculaire procure un taux de réponse élevé et entraîne peu d'effets indésirables.
Les répondants ont bénéficié d'une amélioration de leur MAVC et de la structure épithéliale.
Cela dit, on a enregistré un taux de récurrence élevé pendant le traitement d'entretien
administré tous les 2 mois.
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Article Info
Publication History
Published online: April 03, 2019
Accepted:
January 3,
2019
Received in revised form:
January 3,
2019
Received:
August 3,
2018
Identification
Copyright
© 2019 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.
