Status:
COMPLETED
A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Allergan
Collaborating Sponsors:
Sirna Therapeutics Inc.
Conditions:
Age-Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in t...
Eligibility Criteria
Inclusion
- Active AMD with Subfoveal CNV (classic and/or occult CNV)
- CNV lesion thickness \>/= 250um by OCT assessment
- Visual acuity in study eye of \</= 20/100 but not worse than 20/800
- Not eligible for or refused standard treatment
Exclusion
- Females of childbearing potential
- Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
- Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry
- CNV lesion \>/= 12 MPS disc area
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00363714
Start Date
November 1 2004
End Date
April 1 2007
Last Update
August 18 2008
Active Locations (2)
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1
Baltimore, Maryland, United States
2
Cleveland, Ohio, United States