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)

• 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.

Age-related macular degeneration (AMD) represents the most common cause of blindness in persons over the age of 50. The major cause of vision loss in this disease is due to the development of new blood vessels under the macula. Currently there are several approved treatments for wet AMD. Visudyne therapy, which uses light to activate a drug, called verteporfin. This treatment selectively destroys the leaky, abnormal blood vessels of the retina. Macugen and Lucentis are the other treatments, which are available. Both prevent the growth of abnormal blood vessels by blocking a substance called vascular endothelial growth factor or VEGF.

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.

Participants with a diagnosis of wet age-related macular degeneration, and who are willing to provide consent may be eligible to participate in the VERTACL study.

Inclusion Criteria:

• Drusen > 63 mm
• Choroidal neovascularization under the fovea (Predominantly Classic, Minimally Classic, and Occult lesions acceptable - no reading center confirmation required)
• 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 activiy confirmed by FA or OCT within 4-8 weeks after the last injection

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

• 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

Recruiting. Comments:

Terminated. Comments: The study was stopped due to low patient enrollment.

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