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)
Completed · Phase 1/Phase 2
Conditions studied: Age-Related Macular Degeneration, Choroidal Neovascularization
In brief
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 the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.
Key facts
- Study ID
- NCT00363714
- Run by
- Allergan
- People needed
- 26
- Starts
- 2004-11-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2008-08-18
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Baltimore, Maryland, United States
- Study site — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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