NCT00464347

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Eye Institute (NEI) · NIH
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Avastin
PROCEDURE	Photodynamic Therapy (PDT)
DRUG	Preservative-Free Triamcinolone Acetonide (TAC-PF)

Timeline

• Start date: 2007-01-01
• Completion: 2007-09-01
• First posted: 2007-04-23
• Last updated: 2010-03-24

Locations

11 sites across 1 country: United States