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

Condition(s) targeted: Age-Related Macular Degeneration

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

Phase: Phase 2

Status: Terminated

Sponsored by: National Eye Institute (NEI)

Official(s) and/or principal investigator(s):
Karl G Csaky, MD, PhD, Study Chair, Affiliation: Duke University

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.

Official title: 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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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.

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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Retinal Group of Florida, Ft. Lauderdale, Florida 33334, United States

Central Florida Retina- Orlando, Orlando, Florida 32746, United States

Retina Specialists, Pensacola, Florida 32503, United States

Elman Retina Group- Baltimore, Baltimore, Maryland 21237, United States

Associated Retinal Consulants, Grand Rapids, Michigan 49546, United States

VitroRetinal Surgery, Minneapolis, Minnesota 55435, United States

Duke University Eye Center, Durham, North Carolina 27710, United States

Palmetto Retina Center, Columbia, South Carolina 29204, United States

Southeastern Retina Associates, Knoxville, Tennessee 37909, United States

Texas Retina Associates-Dallas, Dallas, Texas 85231, United States

Texas Retina Associates-Arlington, Arlington, Texas 76012, United States

NEI Clinical Studies Database

Starting date: January 2007
Ending date: September 2007
Last updated: October 15, 2007