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

NCT00877032

Last updated date
Study Location
Dedicated Phase 1
Phoenix, Arizona, 85013, United States
Contact
1-800-718-1021

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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.

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Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular DegenerationSafety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
NCT00877032
  1. Phoenix, Arizona
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ALL GENDERS
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Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular DegenerationSafety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
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  4. Tampa, Florida
  5. Tampa, Florida
  6. Augusta, Georgia
  7. Augusta, Georgia
  8. Augusta, Georgia
  9. Rochester, New York
  10. West Columbia, South Carolina
  11. Abilene, Texas
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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Arm 1
Interventions:
  • Biological: RN6G
  • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
45
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877032
Other Study ID Numbers  ICMJE B1181001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

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