Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00877032
First received: April 6, 2009
Last updated: November 8, 2011
Last verified: November 2011
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
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| 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
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, 84106 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84124 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
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 May 23, 2013