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)

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2007

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Single intravitreal injection
  • Experimental: 2
    • Single intravitreal injection
  • Experimental: 3
    • Single intravitreal injection
  • Experimental: 4
    • Single intravitreal injection
  • Experimental: 5
    • Single intravitreal injection
  • Experimental: 6
    • Single intravitreal injection

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events
    • Time Frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84

Secondary Measures

  • Visual Acuity using the Diabetic Retinopathy Study chart
    • Time Frame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
  • IOP
    • Time Frame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
  • OCT
    • Time Frame: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
  • Fluorescein Angiography (FA)
    • Time Frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Collaborator
    • Sirna Therapeutics Inc.
  • Provider of Information About this Clinical Study
    • Therapeutic Area Head, Allergan, Inc.
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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