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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)

NCT00363714 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2008-08-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

  • Sirna Therapeutics Inc.

    collaborator INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363714 on ClinicalTrials.gov