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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)

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT00363714
Collaborator
Sirna Therapeutics Inc. (Industry)
26
Enrollment
2
Locations
6
Arms
28.9
Duration (Months)
13
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Single intravitreal injection

Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027

    		•
    Experimental: 2

    Single intravitreal injection

    Drug: AGN211745
    200microgram single intravitreal injection
    Other Names:
  • Sirna-027

    		•
    Experimental: 3

    Single intravitreal injection

    Drug: AGN211745
    400microgram single intravitreal injection
    Other Names:
  • Sirna-027

    		•
    Experimental: 4

    Single intravitreal injection

    Drug: AGN211745
    800microgram single intravitreal injection
    Other Names:
  • Sirna-027

    		•
    Experimental: 5

    Single intravitreal injection

    Drug: AGN211745
    1200microgram single intravitreal injection
    Other Names:
  • Sirna-027

    		•
    Experimental: 6

    Single intravitreal injection

    Drug: AGN211745
    1600microgram single intravitreal injection
    Other Names:
  • Sirna-027

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84]

    Secondary Outcome Measures

    1. Visual Acuity using the Diabetic Retinopathy Study chart [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]

    2. IOP [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]

    3. OCT [Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84]

    4. Fluorescein Angiography (FA) [Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baltimore Maryland United States
    2 Cleveland Ohio United States

    Sponsors and Collaborators

    • Allergan
    • Sirna Therapeutics Inc.

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00363714
    Other Study ID Numbers:
    • SIRNA 0401
    • AGN211745
    • NCT00495742
    First Posted:
    Aug 15, 2006
    Last Update Posted:
    Aug 18, 2008
    Last Verified:
    Aug 1, 2008
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Aug 18, 2008