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Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration

Published:April 03, 2019DOI:https://doi.org/10.1016/j.jcjo.2019.01.004

      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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