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

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NCT01003691

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Study Location
Pfizer Investigational Site
Campbell, California, 95008, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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
60-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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

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  1. Campbell, California
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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Official Title  ICMJE 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
Brief Summary 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.
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: Treatment
Condition  ICMJE
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
Intervention  ICMJE
  • 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
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 7, 2011)		24
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)		32
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years to 85 Years   (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 NCT01003691
Other Study ID Numbers  ICMJE B1181002
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 2013

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