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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

April 6, 2009
November 8, 2011
April 2009
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00877032 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Levels of RN6G over time to determine pharamacokinetic 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 ]
Not Provided
Not Provided
 
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
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)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
  • 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.
Experimental: Arm 1
Interventions:
  • Biological: RN6G
  • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877032
B1181001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP