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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)

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 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: 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: 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: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84 ]
  4. Fluorescein Angiography (FA) [ Time Frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24) ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363714


Locations
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United States, Maryland
Baltimore, Maryland, United States
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Allergan
Sirna Therapeutics Inc.
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00363714    
Obsolete Identifiers: NCT00495742
Other Study ID Numbers: SIRNA 0401
AGN211745
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases