Joachim Wachtlin1,2, Nicole Eter3, Zoran Hasanbasic4, Georgios Keramas4, Christine Rech5, Helmut Sachs6, Harald Schilling7, Peter Wiedemann8, Carsten Framme9. 1. Abteilung für Augenheilkunde, Sankt Gertrauden-Krankenhaus, Paretzer Straße 12, 10713, Berlin, Germany. augenheilkunde@sankt-gertrauden.de. 2. MHB, Medizinische Hochschule Brandenburg, Neuruppin, Germany. augenheilkunde@sankt-gertrauden.de. 3. Klinik für Augenheilkunde, Universitätsklinikum Münster, Münster, Germany. 4. Medizinische Fachabteilung, Bayer Vital GmbH, Leverkusen, Germany. 5. Data Generation, Bayer Vital GmbH, Leverkusen, Germany. 6. Augenklinik, Städtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany. 7. Klinik für Augenheilkunde, St.-Johannes-Hospital, Dortmund, Germany. 8. Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Leipzig, Leipzig, Germany. 9. Klinik für Augenheilkunde, Medizinische Hochschule Hannover, Hannover, Germany.
Abstract
PURPOSE: To investigate the influence of treatment regularity with intravitreal aflibercept injections (IVT-AFL injections) on visual acuity (VA) outcomes in patients with neovascular age-related macular degeneration (nAMD) enrolled in the PERSEUS trial who received at least 7 IVT-AFL injections during the first year. METHODS: This was a post hoc analysis of the PERSEUS trial, a prospective, non-interventional, multicenter cohort study, and included 370 patients with nAMD who had received ≥ 7 IVT-AFL injections during year 1. In addition to the prespecified subgroups of treatment-naïve and previously treated patients, results were compared between patients with regular (n = 209) and irregular (n = 161) treatment. Regular treatment was defined as initial dosing with monthly IVT-AFL injections for 3 months, then bimonthly IVT-AFL injections until month 12. Irregular treatment was defined as any deviation from regular treatment (provided ≥ 7 injections were received). The outcome of primary interest was the mean change in VA from baseline after 12 months. Further outcomes of interest included VA gain or loss, proportion of patients achieving reading vision, and percentage of patients with fluid. RESULTS: At month 12, the mean (± standard deviation, SD) VA improvement from baseline was 6.1 ± 15.6 Early Treatment Diabetic Retinopathy Study letters in the regular cohort and 2.5 ± 16.7 letters in the irregular cohort with ≥ 7 IVT-AFL injections (P = 0.0514). Best results were obtained in the treatment-naïve regular sub-cohort with a mean ± SD VA improvement of 8.0 ± 17.7 letters, whereas treatment-naïve patients with irregular treatment experienced a considerably lower VA gain (2.8 ± 20.0 letters). Irregular treatment consistently correlated with inferior results in treatment-naïve patients. At month 12, the proportion of treatment-naïve patients who had experienced a worsening of ≥ 5 letters was 29.6% in the irregular sub-cohort versus 13.6% in the regular sub-cohort (P = 0.0049). However, among the treatment-naïve patients, the mean number of injections was significantly higher in the irregular than in the regular sub-cohort (8.0 ± 1.2 vs. 7.4 ± 0.6; P = 0.0001). Furthermore, compared with the treatment-naïve, regular sub-cohort, patients in the irregular sub-cohort had more visits (19.1 ± 8.6 vs. 16.1 ± 5.7), VA tests (14.2 ± 6.9 vs. 12.0 ± 4.6), and optical coherence tomography examinations (5.1 ± 3.7 vs. 3.4.0 ± 3.0). CONCLUSIONS: Although irregularly treated patients received more injections and more monitoring visits during the first year of IVT-AFL treatment, they experienced worse VA outcomes than regularly treated patients.
PURPOSE: To investigate the influence of treatment regularity with intravitreal aflibercept injections (IVT-AFL injections) on visual acuity (VA) outcomes in patients with neovascular age-related macular degeneration (nAMD) enrolled in the PERSEUS trial who received at least 7 IVT-AFL injections during the first year. METHODS: This was a post hoc analysis of the PERSEUS trial, a prospective, non-interventional, multicenter cohort study, and included 370 patients with nAMD who had received ≥ 7 IVT-AFL injections during year 1. In addition to the prespecified subgroups of treatment-naïve and previously treated patients, results were compared between patients with regular (n = 209) and irregular (n = 161) treatment. Regular treatment was defined as initial dosing with monthly IVT-AFL injections for 3 months, then bimonthly IVT-AFL injections until month 12. Irregular treatment was defined as any deviation from regular treatment (provided ≥ 7 injections were received). The outcome of primary interest was the mean change in VA from baseline after 12 months. Further outcomes of interest included VA gain or loss, proportion of patients achieving reading vision, and percentage of patients with fluid. RESULTS: At month 12, the mean (± standard deviation, SD) VA improvement from baseline was 6.1 ± 15.6 Early Treatment Diabetic Retinopathy Study letters in the regular cohort and 2.5 ± 16.7 letters in the irregular cohort with ≥ 7 IVT-AFL injections (P = 0.0514). Best results were obtained in the treatment-naïve regular sub-cohort with a mean ± SD VA improvement of 8.0 ± 17.7 letters, whereas treatment-naïve patients with irregular treatment experienced a considerably lower VA gain (2.8 ± 20.0 letters). Irregular treatment consistently correlated with inferior results in treatment-naïve patients. At month 12, the proportion of treatment-naïve patients who had experienced a worsening of ≥ 5 letters was 29.6% in the irregular sub-cohort versus 13.6% in the regular sub-cohort (P = 0.0049). However, among the treatment-naïve patients, the mean number of injections was significantly higher in the irregular than in the regular sub-cohort (8.0 ± 1.2 vs. 7.4 ± 0.6; P = 0.0001). Furthermore, compared with the treatment-naïve, regular sub-cohort, patients in the irregular sub-cohort had more visits (19.1 ± 8.6 vs. 16.1 ± 5.7), VA tests (14.2 ± 6.9 vs. 12.0 ± 4.6), and optical coherence tomography examinations (5.1 ± 3.7 vs. 3.4.0 ± 3.0). CONCLUSIONS: Although irregularly treated patients received more injections and more monitoring visits during the first year of IVT-AFL treatment, they experienced worse VA outcomes than regularly treated patients.
Authors: Robert P Finger; Peter Wiedemann; Francisca Blumhagen; Karin Pohl; Frank G Holz Journal: Acta Ophthalmol Date: 2012-11-22 Impact factor: 3.761
Authors: Philip J Rosenfeld; David M Brown; Jeffrey S Heier; David S Boyer; Peter K Kaiser; Carol Y Chung; Robert Y Kim Journal: N Engl J Med Date: 2006-10-05 Impact factor: 91.245
Authors: Jeffrey S Heier; David M Brown; Victor Chong; Jean-Francois Korobelnik; Peter K Kaiser; Quan Dong Nguyen; Bernd Kirchhof; Allen Ho; Yuichiro Ogura; George D Yancopoulos; Neil Stahl; Robert Vitti; Alyson J Berliner; Yuhwen Soo; Majid Anderesi; Georg Groetzbach; Bernd Sommerauer; Rupert Sandbrink; Christian Simader; Ursula Schmidt-Erfurth Journal: Ophthalmology Date: 2012-10-17 Impact factor: 12.079
Authors: Nicholas Papadopoulos; Joel Martin; Qin Ruan; Ashique Rafique; Michael P Rosconi; Ergang Shi; Erica A Pyles; George D Yancopoulos; Neil Stahl; Stanley J Wiegand Journal: Angiogenesis Date: 2012-06 Impact factor: 9.596
Authors: Frank G Holz; Ramin Tadayoni; Stephen Beatty; Alan Berger; Matteo G Cereda; Rafael Cortez; Carel B Hoyng; Philip Hykin; Giovanni Staurenghi; Stephanie Heldner; Timon Bogumil; Theresa Heah; Sobha Sivaprasad Journal: Br J Ophthalmol Date: 2014-09-05 Impact factor: 4.638
Authors: Frank G Holz; Ramin Tadayoni; Stephen Beatty; Alan Berger; Matteo Giuseppe Cereda; Philip Hykin; Giovanni Staurenghi; Kim Wittrup-Jensen; Andreas Altemark; Jonas Nilsson; Kun Kim; Sobha Sivaprasad Journal: Br J Ophthalmol Date: 2016-03-30 Impact factor: 4.638