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)

This study has been completed.
Sponsor:
Collaborator:
Sirna Therapeutics Inc.
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00363714
First received: August 10, 2006
Last updated: August 14, 2008
Last verified: August 2008

August 10, 2006
August 14, 2008
November 2004
April 2007   (final data collection date for primary outcome measure)
Adverse Events [ Time Frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84 ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00363714 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • OCT [ Time Frame: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84 ] [ Designated as safety issue: No ]
  • Fluorescein Angiography (FA) [ Time Frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24) ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
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)
Not Provided

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Age-Related Macular Degeneration
  • Choroidal Neovascularization
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363714
SIRNA 0401, AGN211745
Not Provided
Therapeutic Area Head, Allergan, Inc.
Allergan
Sirna Therapeutics Inc.
Study Director: Medical Director Allergan
Allergan
August 2008

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