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

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Eye Institute (NEI)
• Collaborator: QLT Inc.
• Treatments: Bevacizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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