Ranibizumab Treatment for Pigment Epithelial Detachment Secondary to Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.

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).