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Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

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NCT01577381

Last updated on April 2, 2020
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Study Location
Scottsdale Medical Imaging
Phoenix, Arizona, 85016 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-Related Maculopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women between the ages of 60 and 90 years.

- Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular
Degeneration.

- Best Corrected Visual Acuity (BCVA) of 20/80 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 geographic atrophy (GA) secondary to dry
Age-Related Macular Degeneration in the study eye.

- History or diagnosis of exudative (wet) Age-Related Macular Degeneration, 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

NCT01577381
Pfizer
Terminated
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

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Descriptive Information
Brief Title  ICMJE Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Official Title  ICMJE A Phase 2 Multi-center, Randomized, Double-masked, Placebo-controlled, Multi-dose Study To Investigate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of Rn6g (Pf-04382923) In Subjects With Geographic Atrophy Secondary To Age-related Macular Degeneration
Brief Summary The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.
Detailed Description The trial was terminated early on April 12, 2013 due to an organizational decision, which was not based on safety or efficacy concerns. Subjects who were already enrolled into the study were followed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Maculopathy
Intervention  ICMJE
  • Biological: RN6G
    Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
  • Biological: Placebo
    Intravenous, 11 doses, 30 minute infusion
Study Arms  ICMJE
  • Experimental: PF-04382923
    Intervention: Biological: RN6G
  • Placebo Comparator: Placebo
    Intervention: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 1, 2014) 		10
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2012) 		276
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women between the ages of 60 and 90 years.
  • Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration.
  • Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye

Exclusion Criteria:

  • Evidence of ocular disease other than geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration in the study eye.
  • History or diagnosis of exudative (wet) Age-Related Macular Degeneration, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 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 Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01577381
Other Study ID Numbers  ICMJE B1181003
2012-000823-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 Center Pfizer
PRS Account Pfizer
Verification Date February 2016

ICMJE     Data element required by the

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

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