Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00877032

Purpose

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

Condition	Intervention	Phase
Age-Related Maculopathy Age-Related Maculopathies Eye Diseases Retinal Degeneration Macular Degeneration	Biological: RN6G Biological: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase 1, Double-Masked, Placebo-Controlled Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of Single, Escalating Doses Of RN6G In Patients With Dry, Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases Macular Degeneration

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence and severity of ocular adverse events [ Time Frame: Throughout the duration of the study ] [ Designated as safety issue: Yes ]
Incidence and severity of systemic adverse events [ Time Frame: Throughout the duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Levels of RN6G over time to determine pharmacokinetic parameters [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ] [ Designated as safety issue: No ]
Temporal changes in plasma levels of Aβ(1-X) (total Aβ) [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ] [ Designated as safety issue: No ]
Levels of antibodies against RN6G [ Time Frame: Day 0, 14, 28, 56, 84, 168 ] [ Designated as safety issue: Yes ]

Enrollment:	57
Study Start Date:	April 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Biological: RN6G intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg. Biological: Placebo intravenous, single dose with experimental dose.

Eligibility

Criteria

Inclusion Criteria:

Be of non-childbearing potential.
Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
BCVA of 20/320 or better in the worst eye.

Exclusion Criteria:

Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
Diagnosis or recent history of clinically significant cerebrovascular disease.
Uncontrolled hypertension.
Uncontrolled Type 1 or Type 2 diabetes mellitus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877032

Locations

United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Pfizer Investigational Site
Phoenix, Arizona, United States, 85014
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Pfizer Investigational Site
Inglewood, California, United States, 90301
Pfizer Investigational Site
Newport Beach, California, United States, 92660
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49048
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78240
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
Pfizer Investigational Site
San Antonio, Texas, United States, 78233
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Bountiful, Utah, United States, 84010
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84106

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00877032 History of Changes
Other Study ID Numbers:	B1181001
Study First Received:	April 6, 2009
Last Updated:	November 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 1
Dry Age Related Macular Degeneration
RN6G

Additional relevant MeSH terms:

Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012