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

Age-Related Macular Degeneration Clinical Trial

— VERTACL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00464347
• Other study ID #: 05-EI-0064
• Status: Terminated
• Phase: Phase 2
• First received: April 19, 2007
• Last updated: March 23, 2010
• Start date: January 2007
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Avastin

Procedure:
• Photodynamic Therapy (PDT)

Drug:
• Preservative-Free Triamcinolone Acetonide (TAC-PF)

Locations

Country	Name	City	State
United States	Texas Retina Associates-Arlington	Arlington	Texas
United States	Elman Retina Group- Baltimore	Baltimore	Maryland
United States	Palmetto Retina Center	Columbia	South Carolina
United States	Texas Retina Associates-Dallas	Dallas	Texas
United States	Duke University Eye Center	Durham	North Carolina
United States	Retinal Group of Florida	Ft. Lauderdale	Florida
United States	Associated Retinal Consulants	Grand Rapids	Michigan
United States	Southeastern Retina Associates	Knoxville	Tennessee
United States	VitroRetinal Surgery	Minneapolis	Minnesota
United States	Central Florida Retina- Orlando	Orlando	Florida
United States	Retina Specialists	Pensacola	Florida

Sponsors (2)

Lead Sponsor	Collaborator
National Eye Institute (NEI)	QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
Secondary	Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
Secondary	Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
Secondary	Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
Secondary	Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
Secondary	Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
Secondary	Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
Secondary	Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
Secondary	Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
Secondary	Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
Secondary	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.
Secondary	The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
Secondary	The mean number of injections by quarter on study following initial induction injections.