Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01003691
First received: October 28, 2009
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.


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: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Masked, Placebo-Controlled Study Evaluating The Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Dosages Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration (AMD) Including Geographic Atrophy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of subjects meeting toxicity or intolerable dose criteria [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent adverse events (TEAEs) categorized by severity and causal relationship to study drug [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Incidence of ocular TEAEs identified by ocular examination, and spontaneously reported, categorized by severity and causal relationship to study drug [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Incidence of systemic TEAEs identified by physical examination, changes in vital signs, ECGs, clinical laboratory assessments, and spontaneously reported, categorized by severity and causal relationship to study drug [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Incidence of positive anti-drug-antibodies (ADA) [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma RN6G concentrations will be measured and used in the determination of pharmacokinetic parameters after the first and after the sixth dose [ Time Frame: Days 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304 ] [ Designated as safety issue: Yes ]
  • Change from baseline (absolute and %) of plasma Aβ(1-x)(total), Aβ(1-40), and Aβ(1-42) concentrations [ Time Frame: Days 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304 ] [ Designated as safety issue: No ]
  • Change from baseline in clinical laboratory assessments, vital signs, and ECGs [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: RN6G
Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
Biological: Placebo
Intravenous, multiple dose with experimental dose

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be of non-child bearing potential
  • Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement
  • BCVA of 20/50 or better in the study eye

Exclusion Criteria:

  • Evidence of ocular disease other than advanced AMD or GA in the study eye
  • History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye
  • Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system
  • Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003691

Locations
United States, California
Pfizer Investigational Site
Campbell, California, United States, 95008
Pfizer Investigational Site
San Jose, California, United States, 95128
Pfizer Investigational Site
San Jose, California, United States, 95124
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33609
Pfizer Investigational Site
Tampa, Florida, United States, 33611
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30907
Pfizer Investigational Site
Augusta, Georgia, United States, 30901
Pfizer Investigational Site
Augusta, Georgia, United States, 30909
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, South Carolina
Pfizer Investigational Site
West Columbia, South Carolina, United States, 29169
United States, Texas
Pfizer Investigational Site
Abilene, Texas, United States, 79606
Pfizer Investigational Site
Abilene, Texas, United States, 79605
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Austin, Texas, United States, 78731
Pfizer Investigational Site
Cedar Park, Texas, United States, 78613
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: NCT01003691     History of Changes
Other Study ID Numbers: B1181002
Study First Received: October 28, 2009
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G

Additional relevant MeSH terms:
Eye Diseases
Macular Degeneration
Retinal Degeneration
Atrophy
Geographic Atrophy
Retinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 20, 2014