Enhanced efficacy associated with early treatment of neovascular age-related macular degeneration with pegaptanib sodium: an exploratory analysis.
OBJECTIVE
To assess the vision benefit of treating early subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) with pegaptanib sodium.


METHODS
Exploratory analyses of week 54 vision outcomes (VEGF Inhibition Study in Ocular Neovascularization study) of subject subgroups with early disease who received 0.3 mg of pegaptanib (Groups 1 [n = 34] and 2 [n = 30]) or sham injections (usual care). Two sets of clinical characteristics typical of early disease defined the subgroups.


RESULTS
Baseline characteristics were generally well balanced between treatment arms. Pegaptanib responder rates (loss of <15 letters of visual acuity) were 76% and 80% in treatment Groups 1 and 2 versus 50% and 57% for usual care Groups 1 and 2 (P = 0.03 and P = 0.05), respectively. Compared with subjects assigned to pegaptanib, those in Groups 1 and 2 receiving usual care on average lost 11.1 letters and 12.7 letters more of visual acuity (P < 0.01 and P < 0.006), respectively. Subjects assigned to usual care were approximately 10 times more likely to have severe vision loss than were those treated with pegaptanib (Group 1, 29% vs. 3%, respectively; P < 0.01). In Group 1, 12% of pegaptanib-treated subjects gained > or =15 letters of visual acuity versus 4% receiving usual care; 20% of Group 2 pegaptanib-treated subjects gained > or =15 letters of visual acuity versus none of the usual care subjects.


CONCLUSIONS
Early detection and treatment with pegaptanib may result in superior vision outcomes in patients with neovascular AMD.
Gonzales
Christine R
CR
Jules Stein Eye Institute and Department of Ophthalmology, David Geffen School of Medicine, UCLA, 200 Stein Plaza, Los Angeles, CA 90095, USA. gonzales@jsei.ucla.edu
D000368:Aged; D000369:Aged, 80 and over; D052157:Aptamers, Nucleotide; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009841:Oligonucleotides / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D052157:Aptamers, Nucleotide; D009841:Oligonucleotides; C495058:pegaptanib