Rahul N Khurana1, Ehsan Rahimy2, W Anthony Joseph3, Namrata Saroj4, Andrea Gibson4, Robert Vitti4, Alyson J Berliner4, Karen Chu4, YenChieh Cheng4, David S Boyer5. 1. Northern California Retina Vitreous Associates, Mountain View, California, USA. 2. Palo Alto Medical Foundation, Palo Alto, California, USA. 3. Ophthalmic Consultants of Boston, Boston, Massachusetts, USA. 4. Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA. 5. Retina-Vitreous Associates Medical Group, Beverly Hills, California, USA. Electronic address: vitdoc@aol.com.
Abstract
PURPOSE: To evaluate outcomes and disease characteristics in eyes with neovascular age-related macular degeneration that receivedintravitreal aflibercept injection (IAI) and ranibizumab every 12 weeks or longer (≥q12 weeks) or less than every 12 weeks (<q12 weeks) during year 2 of VIEW studies. DESIGN: Post hoc analysis of randomized clinical trial data. METHODS: In year 1, eyes received ranibizumab q4 weeks (Rq4), IAI 2 mg q4 weeks (2q4), or IAI 2 mg q8 weeks after 3 monthly injections (2q8). In year 2, eyes received pro re nata treatment, with mandatory treatment at least q12 weeks. RESULTS: At week 96, 218 (42.5%), 284 (53.9%), and 245 (47.9%) eyes treated with Rq4, 2q4, and 2q8, respectively, received treatment at ≥q12-week intervals and 295 (57.5%), 243 (46.1%), and 266 (52.1%) eyes at <12q-week intervals during the second year. Baseline occult-type choroidal neovascularization (CNV) (P = .0156) and retinal fluid (P < .0001) and leakage (P < .0001) at week 52 were associated with <q12-week dosing. Mean best-corrected visual acuity gains from baseline with Rq4, 2q4, and 2q8 at ≥q12-week interval were 8.7, 9.9, and 9.7 letters at week 52 and 8.5, 8.8, and 9.2 letters at week 96, respectively. The corresponding gains with <q12-week dosing were 10.3, 9.7, and 8.9 letters at week 52 and 9.1, 7.7, and 8.1 letters at week 96. CONCLUSIONS: Baseline CNV type other than occult and absence of retinal fluid and leakage at week 52 were significantly associated with ≥q12-week dosing. Vision improvements at week 52 following a year of fixed dosing with ranibizumab and IAI were maintained at week 96 in eyes that received treatment ≥q12 weeks and <q12 weeks.
RCT Entities:
PURPOSE: To evaluate outcomes and disease characteristics in eyes with neovascular age-related macular degeneration that received intravitreal aflibercept injection (IAI) and ranibizumab every 12 weeks or longer (≥q12 weeks) or less than every 12 weeks (<q12 weeks) during year 2 of VIEW studies. DESIGN: Post hoc analysis of randomized clinical trial data. METHODS: In year 1, eyes received ranibizumab q4 weeks (Rq4), IAI 2 mg q4 weeks (2q4), or IAI 2 mg q8 weeks after 3 monthly injections (2q8). In year 2, eyes received pro re nata treatment, with mandatory treatment at least q12 weeks. RESULTS: At week 96, 218 (42.5%), 284 (53.9%), and 245 (47.9%) eyes treated with Rq4, 2q4, and 2q8, respectively, received treatment at ≥q12-week intervals and 295 (57.5%), 243 (46.1%), and 266 (52.1%) eyes at <12q-week intervals during the second year. Baseline occult-type choroidal neovascularization (CNV) (P = .0156) and retinal fluid (P < .0001) and leakage (P < .0001) at week 52 were associated with <q12-week dosing. Mean best-corrected visual acuity gains from baseline with Rq4, 2q4, and 2q8 at ≥q12-week interval were 8.7, 9.9, and 9.7 letters at week 52 and 8.5, 8.8, and 9.2 letters at week 96, respectively. The corresponding gains with <q12-week dosing were 10.3, 9.7, and 8.9 letters at week 52 and 9.1, 7.7, and 8.1 letters at week 96. CONCLUSIONS: Baseline CNV type other than occult and absence of retinal fluid and leakage at week 52 were significantly associated with ≥q12-week dosing. Vision improvements at week 52 following a year of fixed dosing with ranibizumab and IAI were maintained at week 96 in eyes that received treatment ≥q12 weeks and <q12 weeks.
Authors: Paul Mitchell; Frank G Holz; Philip Hykin; Edoardo Midena; Eric Souied; Helmut Allmeier; George Lambrou; Thomas Schmelter; Sebastian Wolf Journal: Retina Date: 2021-09-01 Impact factor: 3.975
Authors: Laurent Kodjikian; Mariacristina Parravano; Andreas Clemens; Rosa Dolz-Marco; Frank G Holz; Marion R Munk; Massimo Nicolò; Federico Ricci; Rufino Silva; S James Talks; Rohini Kumar Verma; Javier Zarranz-Ventura; Sandrine A Zweifel Journal: Eye (Lond) Date: 2021-04-01 Impact factor: 3.775