NCT00363714

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Age-Related Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	AGN211745	100microgram single intravitreal injection
DRUG	AGN211745	200microgram single intravitreal injection
DRUG	AGN211745	400microgram single intravitreal injection
DRUG	AGN211745	800microgram single intravitreal injection
DRUG	AGN211745	1200microgram single intravitreal injection
DRUG	AGN211745	1600microgram single intravitreal injection

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-08-15
• Last updated: 2008-08-18

Locations

2 sites across 1 country: United States