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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00877032
First received: April 6, 2009
Last updated: November 8, 2011
Last verified: November 2011
  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 1

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:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: NCT00877032

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85014
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
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, 78217
Pfizer Investigational Site
San Antonio, Texas, United States, 78233
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78240
United States, Utah
Pfizer Investigational Site
Bountiful, Utah, United States, 84010
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84106
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
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 October 22, 2014