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

This study has been terminated.
(Study was terminated because of poor enrollment.)
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00464347
First received: April 19, 2007
Last updated: March 23, 2010
Last verified: October 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

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.

Estimated Enrollment: 100
Study Start Date: January 2007
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464347

Locations
United States, Florida
Retinal Group of Florida
Ft. Lauderdale, Florida, United States, 33334
Central Florida Retina- Orlando
Orlando, Florida, United States, 32746
Retina Specialists
Pensacola, Florida, United States, 32503
United States, Maryland
Elman Retina Group- Baltimore
Baltimore, Maryland, United States, 21237
United States, Michigan
Associated Retinal Consulants
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
VitroRetinal Surgery
Minneapolis, Minnesota, United States, 55435
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Palmetto Retina Center
Columbia, South Carolina, United States, 29204
United States, Tennessee
Southeastern Retina Associates
Knoxville, Tennessee, United States, 37909
United States, Texas
Texas Retina Associates-Arlington
Arlington, Texas, United States, 76012
Texas Retina Associates-Dallas
Dallas, Texas, United States, 85231
Sponsors and Collaborators
QLT Inc.
Investigators
Study Chair: Karl G Csaky, MD, PhD Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464347     History of Changes
Other Study ID Numbers: 05-EI-0064
Study First Received: April 19, 2007
Last Updated: March 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):
AMD
wet AMD
verteporfin PDT
Avastin
TAC-PF

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014