Laurent Kodjikian1,2,3, Ramin Tadayoni4,5, Eric H Souied6, Stéphanie Baillif7, Solange Milazzo8, Stéphane Dumas9, Joël Uzzan10, Lorraine Bernard2,11,12, Evelyne Decullier13, Laure Huot13, Thibaud Mathis1,2,3. 1. Hospices Civils de Lyon, Centre Hospitalier Universitaire de la Croix-Rousse, Service d'Ophtalmologie, France. 2. Université Lyon 1, Lyon, France. 3. UMR-CNRS 5510, Matéis, Villeurbanne, Lyon. 4. Université de Paris, Service d'Ophtalmologie, AP-HP, Hôpital Lariboisière, Paris, France. 5. Fondation Ophtalmologique Adolphe de Rothschild, Service d'Ophtalmologie, Paris, France. 6. Université Paris Est Créteil, Hôpital Intercommunal de Créteil, Créteil, France. 7. Hôpital Pasteur 2, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, France. 8. Hôpital Universitaire d'Amiens-Picardie, Service d'Ophtalmologie, Amiens, France. 9. Centre Nordretine, Lille, France. 10. Clinique Mathilde, Pôle Ophtalmologie, Département Rétine, Rouen, France. 11. Hospices Civils de Lyon, Pôle de Santé Publique, Service de Biostatistique et Bioinformatique, Lyon, France. 12. CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbane, France; and. 13. Hospices Civils de Lyon, Pôle de Santé Publique, Service Recherche et épidémiologie Cliniques, Lyon, France.
Abstract
PURPOSE: To evaluate the mean change in visual acuity at 52 weeks in patients with idiopathic choroidal neovascularization treated with aflibercept. METHODS: We conducted a prospective noncomparative open-label Phase-II trial. The dosage regimen evaluated in this study was structured into two periods: (1) from inclusion to 20 weeks: a treat-and-extend period composed of three mandatory intravitreal injections, and complementary intravitreal injections performed if needed; (2) from 21 weeks to 52 weeks: a pro re nata period composed of intravitreal injections performed only if needed. RESULTS: A total of 19 patients were included, and 16 completed the 52-week study. At baseline, the mean best corrected visual acuity was 66.56 (±20.72) letters (≈20/50 Snellen equivalent), and the mean central retinal thickness was 376.74 µm (±93.77). At 52 weeks, the mean change in the best-corrected visual acuity was +19.50 (±19.36) letters [95% confidence interval = +9.18 to +29.82]. None of the patients included lost ≥15 letters at 24 weeks or 52 weeks. The mean change in central retinal thickness was -96.78 µm (±104.29) at 24 weeks and -86.22 µm (±112.27) at 52 weeks. The mean number of intravitreal injections was 5.4 (±3.0) at 52-weeks. No ocular serious adverse events related to the treatment were reported. CONCLUSION: The present analysis shows clinically significant functional and anatomical treatment effect of aflibercept in case of idiopathic choroidal neovascularization. The treat-and-extend regimen proposed after the first injection seems adequate to treat most neovessels.
PURPOSE: To evaluate the mean change in visual acuity at 52 weeks in patients with idiopathic choroidal neovascularization treated with aflibercept. METHODS: We conducted a prospective noncomparative open-label Phase-II trial. The dosage regimen evaluated in this study was structured into two periods: (1) from inclusion to 20 weeks: a treat-and-extend period composed of three mandatory intravitreal injections, and complementary intravitreal injections performed if needed; (2) from 21 weeks to 52 weeks: a pro re nata period composed of intravitreal injections performed only if needed. RESULTS: A total of 19 patients were included, and 16 completed the 52-week study. At baseline, the mean best corrected visual acuity was 66.56 (±20.72) letters (≈20/50 Snellen equivalent), and the mean central retinal thickness was 376.74 µm (±93.77). At 52 weeks, the mean change in the best-corrected visual acuity was +19.50 (±19.36) letters [95% confidence interval = +9.18 to +29.82]. None of the patients included lost ≥15 letters at 24 weeks or 52 weeks. The mean change in central retinal thickness was -96.78 µm (±104.29) at 24 weeks and -86.22 µm (±112.27) at 52 weeks. The mean number of intravitreal injections was 5.4 (±3.0) at 52-weeks. No ocular serious adverse events related to the treatment were reported. CONCLUSION: The present analysis shows clinically significant functional and anatomical treatment effect of aflibercept in case of idiopathic choroidal neovascularization. The treat-and-extend regimen proposed after the first injection seems adequate to treat most neovessels.