Status:
TERMINATED
TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration
Lead Sponsor:
National Eye Institute (NEI)
Collaborating Sponsors:
QLT Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 ...
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 outcom...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00464347
Start Date
January 1 2007
End Date
September 1 2007
Last Update
March 24 2010
Active Locations (11)
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1
Retinal Group of Florida
Fort 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