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) - Full Text View

Sponsors and Collaborators:	Allergan Sirna Therapeutics Inc.
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00363714

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 I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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
1: Experimental Single intravitreal injection	Drug: AGN211745 100microgram single intravitreal injection
2: Experimental Single intravitreal injection	Drug: AGN211745 200microgram single intravitreal injection
3: Experimental Single intravitreal injection	Drug: AGN211745 400microgram single intravitreal injection
4: Experimental Single intravitreal injection	Drug: AGN211745 800microgram single intravitreal injection
5: Experimental Single intravitreal injection	Drug: AGN211745 1200microgram single intravitreal injection
6: Experimental Single intravitreal injection	Drug: AGN211745 1600microgram single intravitreal injection

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

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

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	SIRNA 0401, AGN211745
Study First Received:	August 10, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00363714
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Macular degeneration
Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2009