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

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NCT01003691

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Campbell, California, 95008 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01003691
Pfizer
Completed
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy

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[email protected]

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Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
  • 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
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
24
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01003691
B1181002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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