Status:
WITHDRAWN
Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself
Lead Sponsor:
Vitreous -Retina- Macula Consultants of New York
Collaborating Sponsors:
QLT Inc.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D) triple therapy will give similar efficacy and safety results as Lucentis monotherapy.
Detailed Description
Study Design: Patients who have received 2-6 previous treatments with Lucentis monotherapy and who have exudative activity associated with the choroidal neovascularization (CNV) lesion, as confirmed ...
Eligibility Criteria
Inclusion
- Main
- Patients with subfoveal CNV due to AMD who, after 2-6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4-8 weeks after the last treatment. Exudative activity is defined as one or more of:
- CNV leakage confirmed by FA
- New hemorrhage associated with the CNV lesion
- Subretinal fluid or cystoid macular edema by OCT showing retinal thickness ≥ 230 μm
- All lesion composition types with a lesion greatest linear dimension (GLD) ≤ 5400 microns (approximately ≤ 9 disc areas \[DA\])
- Best corrected ETDRS VA score of 25-73 letters (approximate Snellen equivalent of 20/40-20/320)
- Main
Exclusion
- Subfoveal geographic atrophy or subfoveal fibrosis in the study eye
- Intraocular surgery within 3 months of enrollment
- Inability to attend the protocol-required visits
- Known allergies or hypersensitivity to any of the study treatments
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00457678
Start Date
January 1 2007
End Date
December 4 2007
Last Update
August 23 2017
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