OBJECTIVES: To assess durability of visual and anatomic gains with 2.0 mg ranibizumab in recalcitrant neovascular age-related macular degeneration (AMD). METHODS: Phase I-II trial of 88 patients with recalcitrant neovascular AMD treated as needed every 4 (cohort A) or 6 weeks (cohort B) following three monthly doses. ETDRS refraction and spectral-domain OCT-guided as-needed re-treatments. RESULTS:Seventy-nine patients completed the 12-month endpoint and were given 11.6 (cohort A) and 8.6 (cohort B) mean treatments. Mean best corrected visual acuity gains of 4.1 letters following three monthly doses were sustained for 12 months for both cohorts. Anatomic improvements were sustained for 12 months for cohort A, but not for cohort B; cohort B demonstrated a gradual increase in mean central retinal thickness (P = .03). CONCLUSION:Visual and anatomic gains achieved with 2.0 mg ranibizumab in recalcitrant neovascular AMD were sustained for 1 year with monthly treatment. In comparison, anatomic gains were diminished with less than monthly treatment. Copyright 2013, SLACK Incorporated.
RCT Entities:
OBJECTIVES: To assess durability of visual and anatomic gains with 2.0 mg ranibizumab in recalcitrant neovascular age-related macular degeneration (AMD). METHODS: Phase I-II trial of 88 patients with recalcitrant neovascular AMD treated as needed every 4 (cohort A) or 6 weeks (cohort B) following three monthly doses. ETDRS refraction and spectral-domain OCT-guided as-needed re-treatments. RESULTS: Seventy-nine patients completed the 12-month endpoint and were given 11.6 (cohort A) and 8.6 (cohort B) mean treatments. Mean best corrected visual acuity gains of 4.1 letters following three monthly doses were sustained for 12 months for both cohorts. Anatomic improvements were sustained for 12 months for cohort A, but not for cohort B; cohort B demonstrated a gradual increase in mean central retinal thickness (P = .03). CONCLUSION: Visual and anatomic gains achieved with 2.0 mg ranibizumab in recalcitrant neovascular AMD were sustained for 1 year with monthly treatment. In comparison, anatomic gains were diminished with less than monthly treatment. Copyright 2013, SLACK Incorporated.
Authors: D S Dhoot; D J Pieramici; M Nasir; A A Castellarin; S Couvillion; R F See; N Steinle; M Bennett; M Rabena; R L Avery Journal: Eye (Lond) Date: 2015-01-30 Impact factor: 3.775