TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration

Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration

VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

The VERTACL study is a multi-center, randomized, Phase II trial to investigate whether a triple therapy, Avastin®, half fluence verteporfin PDT, and TAC- PF, results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

Participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (Avastin®), or triple therapy (Avastin®, half fluence verteporfin PDT, and TAC- PF). Participants in the Avastin® alone arm will receive 1.25 mg intravitreal Avastin®, at every study visit. Participants in the triple-therapy arm will receive all treatments (Avastin®, half fluence verteporfin PDT, and TAC- PF) at baseline.

Following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (PRN) basis if protocol-specific re-treatment criteria are met. After randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment.

Participants will return to the clinic at month 24 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography, and fundus photography.

Inclusion Criteria Includes:

• Drusen > 63 mm
• Choroidal neovascularization under the fovea (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
• Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
• ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
• Total area of lesion must < 9 MPS DA
• 0-3 intravitreal injections of anti-VEGF monotherapy within 6 months of randomization with continuing evidence of exudative activity confirmed by FA or OCT within 4-8 weeks after the last injection

Exclusion Criteria Includes:

• Oral steroid use within 6 months
• Prior complications from steroid therapy
• Prior stroke, myocardial infarction, or end-stage malignancy

Study Eye Exclusion Criteria

• Geographic atrophy or fibrosis under the fovea
• Fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion
• Prior treatment with verteporfin within 12 months
• IOP is >25 mmHg and the participant is on Cosopt
• Intraocular surgery within 6 weeks
• Prior vitrectomy
• Peribulbar steroid injection within 6 months
• Poor reactions to topical or periocular steroid treatment including elevated IOP