Abstract
Purpose::
To evaluate the effectiveness and safety of pegaptanib combined with moxifloxacin for the treatment of patients with neovascular age-related macular degeneration (AMD).
Methods::
Patients ≥50 years of age with all sizes and angiographic subtypes of subfoveal choroidal neovascularization secondary to AMD, and best-corrected visual acuities (BCVAs) of 20/40 to 20/800 were eligible. Active untreated lesions and lesions previously treated with photodynamic therapy or intravitreous or subtenon kenalog were eligible. Patients received combination treatment of pegaptanib 0.3mg with 135µg/0.1 mL moxifloxacin every 6 weeks for the first six months and subsequently the patients received only pegaptanib. Before injection and 4-5 days post-injection, BCVA was assessed with ETDRS charts. The primary endpoint was the percentage of eyes losing <15 letters from baseline to month 12; secondary endpoints at month 12 were percentages of eyes with stable or improved vision and with gains of ≥15 letters, and mean change in BCVA.
Results::
Twelve-month follow-up has been completed for 70 eyes (14 with no previous treatment) of 66 patients. Loss of <15 letters from baseline to week 12 was seen in 68/70 (97.1%) eyes overall, including 14/14 (100%) with de novo lesions and 54/56 (96.4%) previously treated eyes. Stable or improved vision was seen in 55/70 (78.6%), 11/14 (78.6%), and 44/56 (78.6%) eyes, respectively, and gains of ≥15 letters were noted in 14/70 (20.0%), 4/14 (28.6%), and 10/56 (17.9%) eyes, respectively. At month 12, BCVA improved by a mean of 5.4 letters overall and by 9.21 letters in de novo patients. Adverse events were mild and related to the injection procedure; endophthalmitis was not observed in any patient.
Conclusions::
Pegaptanib combined with moxifloxacin appears to be effective and safe in treating neovascular AMD.
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • antibiotics/antifungals/antiparasitics