Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01003691
First received: October 28, 2009
Last updated: March 27, 2013
Last verified: March 2013
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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:
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 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 May 16, 2013