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
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Choroidal Neovascularization
Drug: AGN211745
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ] [ 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 ]

Enrollment: 26
Study Start Date: November 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Name: Sirna-027
Experimental: 2
Single intravitreal injection
Drug: AGN211745
200microgram single intravitreal injection
Other Name: Sirna-027
Experimental: 3
Single intravitreal injection
Drug: AGN211745
400microgram single intravitreal injection
Other Name: Sirna-027
Experimental: 4
Single intravitreal injection
Drug: AGN211745
800microgram single intravitreal injection
Other Name: Sirna-027
Experimental: 5
Single intravitreal injection
Drug: AGN211745
1200microgram single intravitreal injection
Other Name: Sirna-027
Experimental: 6
Single intravitreal injection
Drug: AGN211745
1600microgram single intravitreal injection
Other Name: Sirna-027

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363714

Locations
United States, Maryland
Baltimore, Maryland, United States
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Allergan
Sirna Therapeutics Inc.
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00363714     History of Changes
Obsolete Identifiers: NCT00495742
Other Study ID Numbers: SIRNA 0401, AGN211745
Study First Received: August 10, 2006
Last Updated: August 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 22, 2014