Abstract
Purpose: :
To describe the extent of best-corrected visual acuity (BCVA) recovery after a single ranibizumab retreatment in SUSTAIN study patients who followed a PRN regimen from Month 3 onwards.
Methods: :
In the open-label, multi-center, single-arm SUSTAIN study of 12 months duration, 513 patients with age-related macular degeneration (AMD) received 3 initial monthly injections of ranibizumab (0.3 mg) and re-treatment with ranibizumab (0.3/0.5 mg) in the maintenance phase when they either lost >5 letters in BCVA or their central retinal thickness (CRT) increased by >100 µm, with the option not to treat when CRT ≤ 225 µm or BCVA ≥ 79 letters. The response to a single injection during the maintenance phase was analyzed under different conditions regarding AMD characteristics, demographics, treatment, and response history.
Results: :
Based on an interim analysis of 69 patients, patients who lost >5 letters of BCVA in the maintenance phase responded to the subsequent ranibizumab injection with an average BCVA gain of about 3 letters. For approx. half of these patients this injection took place after at least 4 months without treatment. Results of the entire patient population will also be presented. BCVA gain correlates stronger to the short-term loss than to the overall loss of visual acuity.
Conclusions: :
The results suggest that in patients whose BCVA decreased by >5 letters after the loading phase, a single injection of ranibizumab in the maintenance phase can bring back vision in a magnitude similar to what is seen for the initial injection at baseline.
Clinical Trial: :
www.clinicaltrials.gov NCT00331864
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • visual acuity