Slakter 2006.

Methods	Method of randomization: Not explicitly reported (“randomized”). Method of allocation concealment: Not clearly reported. Masking of participants and care-givers: Participants were masked (covered infusion-tubing, similar set of instructions as indicated for PDT. Physicians administering the medication were not. Masking of outcome assessment: Yes, outcome assessors were masked. Losses to follow-up: Only 3 participants in the PDT group and none in the anecortave acetate group were lost to follow-up. Data from 18.6% in anecortave acetate group and 17.6% in PDT group were not available for 12-month analyses. Intention-to-treat analysis: The trial was designed as a non-inferiority study and the authors reported a per-protocol analysis as well as an intention-to-treat with the last observation carried forward. Reported sample size calculation: Yes, an a priori sample size calculation was reported. 261 per group to provide 90% coverage probability to achieve non-inferiority margin of 7% points.
Participants	# randomized in treatment arm: 263 #randomized in control arm: 267 Inclusion criteria: Patients were at least 50 years old. Patients could be of any race or gender. A clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal CNV lesion in the study eye. A best corrected Early Treatment Diabetic Retinopathy Study visual acuity of 0.30 (20/40 Snellen) to1.30 (20/400 Snellen) in the study eye at the screening visit. Exclusion criteria: History of any condition that would likely compromise visual acuity in the study eye. History of any medical condition that would preclude scheduled study visits or completion of the study. Myopic retinopathy or refraction > -8 diopter power. Photodynamic treatments of any kind. Past ocular surgery within 60 days including laser photocoagulation within 30 days. A scleral buckle in the study eye. Use of any investigational agent for AMD within 30 days before administration of study medication. Previous experimental procedure or systemically administered antiangiogenic therapy for exudative AMD in either eye, including anecortave acetate treatment of the fellow eye. Allergy or sensitivity to steroids or verteporfin. IV or subcutaneous anticoagulant therapy or patient on oral anticoagulant therapy. Medical history of porphyria. Clinical evidence of scleral thinning. Patients whose screening fluorescin angiographic images could not be adequately visualized by the investigator and the digital angiography reading center. Age: Average age was 76.6 years (51-96 years), group-wise data not provided. Gender: Overall, 52% were females, no group-wise data available Equivalence of baseline characteristics: Age, gender, mean baseline visual acuity were similar at baseline
Interventions	Treatment: Posterior juxtascleral depot administration of 15 mg anecortave acetate every 6 months, a sham PDT every 3 months if there was leakage on fluorescein angiogram. Control: PDT, administered every 3 months and influenced by investigator's decision based on fluorescein angiographic evidence of leakage, and sham anecortave acetate at baseline and at 6 months.
Outcomes	Primary outcome: Visual acuity, measured as loss of fewer than 3 lines of vision at month 12. Visual acuity was measured at 2 meters using the ETDRS and TAP study methodology. Visual acuity was also reported as logMAR scores. Secondary outcomes: Safety outcomes/adverse events.
Notes	Country: USA, Canada, Europe, Israel, Australia. Time of study: Not reported.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

AMD: age-related macular degeneration

BCVA: best corrected visual acuity

CNV: choroidal neovascularization

ETDRS: early treatment diabetic retinopathy study

PDT: photodynamic therapy

TAP: treatment of age-related macular degeneration with photodynamic therapy