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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single

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.

Interventions

  • Drug: Avastin
  • Procedure: Photodynamic Therapy (PDT)
  • Drug: Preservative-Free Triamcinolone Acetonide (TAC-PF)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Eye Institute (NEI)
  • Collaborator
    • QLT Inc.
  • Overall Official(s)
    • Karl G Csaky, MD, PhD, Study Chair, Duke University

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