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

• The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
  

• Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
  
• Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
  
• Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
  
• Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
  
• Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
  
• Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
  
• Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
  
• Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
  
• Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
  
• Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 175 microns) of ³50% and of at least 50 microns from baseline to months 3, 6, 12, and 24.
  
• The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
  
• The mean number of injections by quarter on study following initial induction injections.
  

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.