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

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00464347

Collaborator

QLT Inc. (Industry)

100

Enrollment

Locations

Duration (Months)

9.1

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Drug: Avastin Procedure: Photodynamic Therapy (PDT) Drug: Preservative-Free Triamcinolone Acetonide (TAC-PF)	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Group of Florida	Ft. Lauderdale	Florida	United States	33334
2	Central Florida Retina- Orlando	Orlando	Florida	United States	32746
3	Retina Specialists	Pensacola	Florida	United States	32503
4	Elman Retina Group- Baltimore	Baltimore	Maryland	United States	21237
5	Associated Retinal Consulants	Grand Rapids	Michigan	United States	49546
6	VitroRetinal Surgery	Minneapolis	Minnesota	United States	55435
7	Duke University Eye Center	Durham	North Carolina	United States	27710
8	Palmetto Retina Center	Columbia	South Carolina	United States	29204
9	Southeastern Retina Associates	Knoxville	Tennessee	United States	37909
10	Texas Retina Associates-Arlington	Arlington	Texas	United States	76012
11	Texas Retina Associates-Dallas	Dallas	Texas	United States	85231