Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363714
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : August 18, 2008
Sponsor:
Collaborator:
Sirna Therapeutics Inc.
Information provided by:
Allergan

Tracking Information
First Submitted Date  ICMJE August 10, 2006
First Posted Date  ICMJE August 15, 2006
Last Update Posted Date August 18, 2008
Study Start Date  ICMJE November 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
Adverse Events [ Time Frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2006)
  • Study eye will be examined (fundus and tonometry) at 30 minutes post injection to ensure adequate ocular perfusion and normal intraocular pressure. Patients observed for 4 hours post incection.
  • PK sample draws at baseline, day 1, 2 and 7.
  • Routine eye exam for safety follow-up visits at 6, 9, 12, 18 and 24 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2006)
  • Complete ophtamlic evaluation with tonometry, fundus photography, optical coherence tomography (OCT), and flourescein angiography at screening and study days 7, 14, 28, and 84.
  • Visual accuity using the Dabetic Retinopathy Study chart at every study visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Age-Related Macular Degeneration
  • Choroidal Neovascularization
Intervention  ICMJE
  • Drug: AGN211745
    100microgram single intravitreal injection
    Other Name: Sirna-027
  • Drug: AGN211745
    200microgram single intravitreal injection
    Other Name: Sirna-027
  • Drug: AGN211745
    400microgram single intravitreal injection
    Other Name: Sirna-027
  • Drug: AGN211745
    800microgram single intravitreal injection
    Other Name: Sirna-027
  • Drug: AGN211745
    1200microgram single intravitreal injection
    Other Name: Sirna-027
  • Drug: AGN211745
    1600microgram single intravitreal injection
    Other Name: Sirna-027
Study Arms  ICMJE
  • Experimental: 1
    Single intravitreal injection
    Intervention: Drug: AGN211745
  • Experimental: 2
    Single intravitreal injection
    Intervention: Drug: AGN211745
  • Experimental: 3
    Single intravitreal injection
    Intervention: Drug: AGN211745
  • Experimental: 4
    Single intravitreal injection
    Intervention: Drug: AGN211745
  • Experimental: 5
    Single intravitreal injection
    Intervention: Drug: AGN211745
  • Experimental: 6
    Single intravitreal injection
    Intervention: Drug: AGN211745
Publications * Kaiser PK, Symons RC, Shah SM, Quinlan EJ, Tabandeh H, Do DV, Reisen G, Lockridge JA, Short B, Guerciolini R, Nguyen QD; Sirna-027 Study Investigators. RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. Am J Ophthalmol. 2010 Jul;150(1):33-39.e2. doi: 10.1016/j.ajo.2010.02.006.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2006)
26
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00363714
Other Study ID Numbers  ICMJE SIRNA 0401
AGN211745
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Allergan, Inc.
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Sirna Therapeutics Inc.
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP