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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avastin
Photodynamic Therapy (PDT)
Preservative-Free Triamcinolone Acetonide (TAC-PF)
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, wet AMD, verteporfin PDT, Avastin, TAC-PF

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Retinal Group of Florida
  • Central Florida Retina- Orlando
  • Retina Specialists
  • Elman Retina Group- Baltimore
  • Associated Retinal Consulants
  • VitroRetinal Surgery
  • Duke University Eye Center
  • Palmetto Retina Center
  • Southeastern Retina Associates
  • Texas Retina Associates-Arlington
  • Texas Retina Associates-Dallas

Outcomes

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.

Full Information

First Posted
April 19, 2007
Last Updated
March 23, 2010
Sponsor
National Eye Institute (NEI)
Collaborators
QLT Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00464347
Brief Title
TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated because of poor enrollment.
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)
Collaborators
QLT Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, wet AMD, verteporfin PDT, Avastin, TAC-PF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy (PDT)
Intervention Type
Drug
Intervention Name(s)
Preservative-Free Triamcinolone Acetonide (TAC-PF)
Primary Outcome Measure Information:
Title
The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
Secondary Outcome Measure Information:
Title
Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
Title
Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
Title
Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
Title
Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
Title
Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
Title
Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
Title
Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
Title
Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
Title
Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
Title
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.
Title
The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
Title
The mean number of injections by quarter on study following initial induction injections.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl G Csaky, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Retinal Group of Florida
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Central Florida Retina- Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Retina Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Elman Retina Group- Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Associated Retinal Consulants
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
VitroRetinal Surgery
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Palmetto Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Southeastern Retina Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Retina Associates-Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Retina Associates-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
85231
Country
United States

12. IPD Sharing Statement

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

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