Methods	Method of randomization: stochastic treatment allocation algorithm based on the variance method Method of allocation concealment: centralized randomization where the study coordinator was instructed the code of the medication for the patient after determining her eligibility. The medication packet was not opened until just before administering the injection Masking: Participants: yes Care providers: examiner: yes; injector: no Outcome assessors: yes Number randomized: 144 to 0.3 mg pegaptanib, 146 to 1 mg pegaptanib, 143 to 3 mg pegaptanib, and 145 to placebo groups Exclusions after randomization: none Number analyzed: 144 in 0.3 mg pegaptanib, 146 in 1 mg pegaptanib, 143 in 3 mg pegaptanib, and 145 in placebo groups for the primary outcome alone Losses to follow up: 11 in placebo group, 12 in 0.3 mg pegaptanib group, 17 in 1 mg pegaptanib group, 20 in 3 mg pegaptanib group discontinued therapy during the trial Intention to treat analysis: reported an intention to treat analysis only for the primary outcome Unit of analysis: individuals Reported power calculations: yes
Participants	Country: USA, Canada Age: Mean age was 78, 76.5, 77.1, and 76.7 years in 0.3 mg pegaptanib, 1 mg pegaptanib, 3 mg pegaptanib, and placebo groups, respectively Gender: 56%, 53%, 69%, and 57% in 0.3 mg pegaptanib, 1 mg pegaptanib, 3 mg pegaptanib, and placebo groups respectively, were females Inclusion criteria: age greater than or equal to 50 years; subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration; best corrected visual acuity of 20/40 to 20/320 in the treated eye and greater than 20/800 in the fellow eye; CNV lesion may be predominantly classic, minimally classic, occult with no classic; size of lesion < 12 disc areas (including blood, scar/atrophy, neovascularization); no greater than 50% of lesion could be due to subretinal hemorrhage and 50% of lesion had to be due to CNV; for occult lesions, lesions had to be subretinal and no greater than 50% of total lesion area, or presence of lipid or loss of 15 letters or more of visual acuity during previous 12 weeks; patients were eligible even if they received 1 photodynamic treatment if it was at least 8 to 12 weeks prior to enrollment; intraocular pressure < 23 mmHg; adequate pupil dilation; clear media Exclusion criteria: atrophy exceeding 20% of total lesion or subfoveal scarring; previous thermal laser; therapy with another investigational drug; likelihood of requiring cataract removal within 2 years; other potential causes of CNV including high myopia, ocular histoplasmosis, angioid streaks, choroidal rupture, multifocal choroiditis, any intraocular surgery within 3 months or extrafoveal/juxtafoveal laser within 2 weeks of study entry or posterior vitrectomy or scleral buckle or presence of intraretinal tears or rips; concomitant presence of diabetic retinopathy, severe cardiac disease, myocardial infarction within 6 months, ventricular tachycardia requiring treatment, unstable angina, evidence of peripheral vascular disease, stroke within 12 months, acute or chronic periocular infection, previous therapeutic radiation to eye/head/neck; any treatment with any investigational agent within past 30 days; serious allergies to fluorescein dye or indocyanine green or components of pegaptanib Equivalence of baseline characteristics: The treatment groups were similar with respect to age, gender, race, smoking status, angiographic subtypes, prior treatment status with photodynamic therapy, and Early Treatment Diabetic Retinopathy Study visual acuity scores
Interventions	Treatment: Intravitreal injection of pegaptanib at dosages of either 0.3 mg, 1.0 mg, or 3.0 mg given every 6 weeks over period of 48 weeks Control: sham injection with patients treated identically with the exception of scleral penetration with the needle Length of follow-up: 54 weeks
Outcomes	Primary outcome: proportion of patients losing fewer than 15 letters of visual acuity between baseline and week 54 Other outcomes reported: Gain of 3 or more lines visual acuity, maintenance of visual acuity or gain of 0 lines of visual acuity, mean visual acuity, legal blindness, loss of 30 letters or more of visual acuity, size of lesion, and total CNV size Reported quality of life indicators: yes Intervals at which outcome assessed: every 6 weeks before treatment with main assessment analyzed after 54 weeks
Notes	Funding: Eyetech Pharmaceuticals and Pfizer NCT00321997