Abstract
Purpose: :
To describe the best-corrected visual acuity (BCVA) and central retinal thickness (CRT) response profiles and ranibizumab treatment patterns of patients with neovascular age-related macular degeneration (AMD) included in the interim analysis of the SUSTAIN study.
Methods: :
The interim analysis of the open-label, multi-center, single-arm 12 month study included 69 ranibizumab-naïve AMD patients who received 3 initial monthly injections of ranibizumab (0.3 mg) and ranibizumab (0.3/0.5 mg) re-treatment in the maintenance phase when they either lost >5 letters in BCVA compared to the highest prior BCVA score or their CRT increased by >100 µm from the lowest prior value. No re-treatment was given if CRT was <225 µm or BCVA ≥79 letters. BCVA (Early Treatment for Diabetic Retinopathy Study charts) and CRT (optic coherence tomography) were assessed monthly.
Results: :
Patients received an average of 2.3 injections in the maintenance phase (0-7 injections). This average injection number resulted in a gain in mean BCVA from baseline to Months 3 and 12 of 9.2 and 6.7 letters, respectively. 26% gained ≥15 letters and 3% lost >15 letters at Month 12 compared with baseline. Mean CRT decreased from baseline to Months 3 and 12 by 89.6 and 78.7 µm, respectively. Individual patient profiles could not be clearly categorized into treatment response patterns. However, several patients were identified whose BCVA and CRT values remained either stable in the maintenance phase without re-treatment or whose BCVA and CRT levels were variable and whose injection-related BCVA increase was typically mirrored by a decrease in CRT. Other patients were found whose BCVA or CRT merely responded to ranibizumab re-treatments.
Conclusions: :
The analysis of BCVA and CRT response and treatment patterns suggests that a combined assessment of patients’ BCVA and CRT profiles is helpful in determining adequate individual treatment regimens.
Clinical Trial: :
www.clinicaltrials.gov NCT00331864
Keywords: age-related macular degeneration • vascular endothelial growth factor • visual acuity