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

Last updated on December 15, 2017

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Study Location
Dedicated Phase 1
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00877032
Pfizer
Completed
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

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Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
A Phase I, 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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00877032
B1181001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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