David Sarraf1, Nikolas J S London2, Rahul N Khurana3, Pravin U Dugel4, Shamika Gune5, Lauren Hill5, Lisa Tuomi5. 1. Retinal Disorders and Ophthalmic Genetics Division, Stein Eye Institute, University of California, Los Angeles, Los Angeles, California; Greater Los Angeles VA Healthcare Center, Los Angeles, California. Electronic address: dsarraf@ucla.com. 2. Retina Consultants San Diego, Poway, California. 3. Northern California Retina Vitreous Associates, Mountain View, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California. 4. Retinal Consultants of Arizona, Retinal Research Institute, Phoenix, Arizona, and USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California. 5. Genentech, Inc., South San Francisco, California.
Abstract
PURPOSE: To analyze the effect of baseline presence and height of pigment epithelial detachments (PEDs) on visual and anatomic outcomes at 24 months in patients with neovascular age-related macular degeneration (AMD) treated withranibizumab. DESIGN: Post hoc analysis of HARBOR, a 24-month, phase III, randomized, multicenter, double-masked, active treatment-controlled study (clinicaltrials.gov identifier, NCT00891735). PARTICIPANTS: One thousand ninety-seven patients with neovascular AMD. METHODS:Intravitreal ranibizumab 0.5 mg or 2.0 mg monthly or pro re nata (PRN) after 3 monthly loading doses. MAIN OUTCOME MEASURES: We evaluated the effect of presence and height of baseline PED on several outcomes at 24 months, including best-corrected visual acuity (BCVA), change in PED height, resolution of PED, and number of injections in the PRN arms. Development of macular atrophy at month 24 by presence or absence of PED was evaluated. RESULTS:Five hundred ninety-eight (54.5%) patients showed PED at baseline. In the ranibizumab 0.5-mg PRN group, mean numbers of injections were similar for patients with PED present or absent at baseline (14.0 vs. 12.5). Mean BCVA gains from baseline to 24 months were seen in all treatment groups and were comparable in patients with or without PED at baseline treated with ranibizumab 0.5 mg monthly (PED present at baseline, +9.0 letters; PED absent at baseline, +11.3 letters), 0.5 mg PRN (present, +8.4; absent, +7.9), 2.0 mg monthly (present, +7.1; absent, +11.1), or 2.0 mg PRN (present, +7.2; absent, +8.8). When analyzed by baseline PED height, mean BCVA gains were demonstrated and comparable in all treatment groups at 24 months except for patients treated with ranibizumab 2.0 mg monthly in the extra-large group (PEDs ≥352 μm; mean BCVA change, -0.8 letters). At 24 months, 53.2% (0.5 mg monthly), 44.5% (0.5 mg PRN), 70.4% (2.0 mg monthly), and 57.3% (2.0 mg PRN) of patients showed complete resolution of PED. CONCLUSIONS:Ranibizumab 0.5 mg given monthly or PRN effectively treated PEDs in patients with neovascular AMD, and significant vision gains resulted regardless of PED status and height at baseline. In this analysis, there was no additional vision benefit with a higher dose of ranibizumab (2.0 mg).
RCT Entities:
PURPOSE: To analyze the effect of baseline presence and height of pigment epithelial detachments (PEDs) on visual and anatomic outcomes at 24 months in patients with neovascular age-related macular degeneration (AMD) treated with ranibizumab. DESIGN: Post hoc analysis of HARBOR, a 24-month, phase III, randomized, multicenter, double-masked, active treatment-controlled study (clinicaltrials.gov identifier, NCT00891735). PARTICIPANTS: One thousand ninety-seven patients with neovascular AMD. METHODS: Intravitreal ranibizumab 0.5 mg or 2.0 mg monthly or pro re nata (PRN) after 3 monthly loading doses. MAIN OUTCOME MEASURES: We evaluated the effect of presence and height of baseline PED on several outcomes at 24 months, including best-corrected visual acuity (BCVA), change in PED height, resolution of PED, and number of injections in the PRN arms. Development of macular atrophy at month 24 by presence or absence of PED was evaluated. RESULTS: Five hundred ninety-eight (54.5%) patients showed PED at baseline. In the ranibizumab 0.5-mg PRN group, mean numbers of injections were similar for patients with PED present or absent at baseline (14.0 vs. 12.5). Mean BCVA gains from baseline to 24 months were seen in all treatment groups and were comparable in patients with or without PED at baseline treated with ranibizumab 0.5 mg monthly (PED present at baseline, +9.0 letters; PED absent at baseline, +11.3 letters), 0.5 mg PRN (present, +8.4; absent, +7.9), 2.0 mg monthly (present, +7.1; absent, +11.1), or 2.0 mg PRN (present, +7.2; absent, +8.8). When analyzed by baseline PED height, mean BCVA gains were demonstrated and comparable in all treatment groups at 24 months except for patients treated with ranibizumab 2.0 mg monthly in the extra-large group (PEDs ≥352 μm; mean BCVA change, -0.8 letters). At 24 months, 53.2% (0.5 mg monthly), 44.5% (0.5 mg PRN), 70.4% (2.0 mg monthly), and 57.3% (2.0 mg PRN) of patients showed complete resolution of PED. CONCLUSIONS:Ranibizumab 0.5 mg given monthly or PRN effectively treated PEDs in patients with neovascular AMD, and significant vision gains resulted regardless of PED status and height at baseline. In this analysis, there was no additional vision benefit with a higher dose of ranibizumab (2.0 mg).
Authors: Kai Xiong Cheong; Dilraj Singh Grewal; Kelvin Yi Chong Teo; Alfred Tau Liang Gan; Glenn Jay Jaffe; Gemmy Chui Ming Cheung Journal: Eye (Lond) Date: 2020-02-11 Impact factor: 3.775