Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:06
Venue: Room 111
First Author: : I.Stoilov ARGENTINA
Co Author(s): : L. Hill L. Tuomi P. Schlottmann
To describe the key clinical findings relating to the optimal treatment of eyes with neovascular age-related macular degeneration (nAMD) and pigment epithelial detachments (PED) based on data from HARBOR (NCT00891735).
HARBOR was a 24-month, phase III, randomized, multicentre, double-masked, dose-response study of patients with nAMD.
Patients were randomized to 4 ranibizumab (RBZ) treatment groups (0.5 mg monthly [M] and as needed [PRN], or 2.0 mg monthly and PRN) following 3 monthly loading doses. In 1097 study eyes with PED at baseline (BL), best-corrected visual acuity (BCVA), anatomic outcomes, and development of retinal pigment epithelial (RPE) tears or macular atrophy (MA) were evaluated over 24 months. Size analyses used quartiles based on BL PED height (range: ~35–1400 µm at BL).
Quadrupling the dose of anti-VEGF to 2.0 mg demonstrated additional PED resolution at 2 years (0.5 mg, 53.2% [M], 44.5% [PRN]; 2.0 mg, 70.4% [M], 57.3% [PRN]), but average vision gains were lower (mean BCVA change from BL to 2 years: 0.5 mg, +9.0 letters [M], +8.4 [PRN]; 2.0 mg, +7.1 [M], 7.2 [PRN]). No additional vision was gained with complete PED resolution (mean change in BCVA from BL to 2 years: resolution, +8.3 letters; PED present, +7.7). Vision improved regardless of RBZ regimen or PED size at BL (mean BCVA change from BL to 2 years: small: +9.1 letters; medium: +9.0; large: +8.9; X-large: +4.7). A similar mean number of injections was needed in RBZ 0.5-mg PRN arm regardless of BL PED size (small: 12.2; medium: 13.6; large: 14.0; X-large: 15.6). Only 5% of eyes with PED at BL developed an RPE tear, most (79%) by month 3. On average, RBZ-treated eyes with a new on-study nonfoveal-only RPE tear gained vision during the study (nonfoveal-only tear, +3.5 letters [n=20], foveal-involving, −24.5 [n=4]). Complete PED resolution was associated with a higher rate of MA at month 24 than if PED was present (44% vs 17%, respectively; P<.0001).
Ranibizumab 0.5 mg monthly or PRN treatment for nAMD and PED was found to be safe and effective. Although a greater proportion of patients in the higher ranibizumab dose group exhibited complete PED resolution, there was no additional vision benefit.