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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Collaborator: |
QLT Inc |
| Information provided by: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00464347 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2007 |
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 |
Inclusion Criteria Includes:
Exclusion Criteria Includes:
Study Eye Exclusion Criteria
Contacts and 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-Dallas | |
| Dallas, Texas, United States, 85231 | |
| Texas Retina Associates-Arlington | |
| Arlington, Texas, United States, 76012 | |
| Study Chair: | Karl G Csaky, MD, PhD | Duke University |
More Information
| Study ID Numbers: | 05-EI-0064 |
| Study First Received: | April 19, 2007 |
| Last Updated: | October 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00464347 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AMD wet AMD verteporfin PDT Avastin TAC-PF |
|
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bevacizumab Hormones Triamcinolone hexacetonide Triamcinolone Acetonide Therapeutic Uses Triamcinolone Angiogenesis Modulating Agents |
Growth Inhibitors Retinal Diseases Eye Diseases Growth Substances Retinal Degeneration Macular Degeneration Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions |