TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration (VERTACL)
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| ClinicalTrials.gov Identifier: NCT00464347 |
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Recruitment Status :
Terminated
(Study was terminated because of poor enrollment.)
First Posted : April 23, 2007
Last Update Posted : March 24, 2010
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| 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 |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | January 2007 |
| Actual Study Completion Date : | September 2007 |
- The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
- 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464347
| 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 | |
| Study Chair: | Karl G Csaky, MD, PhD | Duke University |
| ClinicalTrials.gov Identifier: | NCT00464347 |
| Other Study ID Numbers: |
05-EI-0064 |
| First Posted: | April 23, 2007 Key Record Dates |
| Last Update Posted: | March 24, 2010 |
| Last Verified: | October 2007 |
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AMD wet AMD verteporfin PDT Avastin TAC-PF |
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Bevacizumab Triamcinolone diacetate Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |