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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 2

Conditions

Age-Related Maculopathy

Treatments

Biological: Placebo
Biological: RN6G

Study type

Interventional

Funder types

Industry

Identifiers

NCT01577381
2012-000823-42 (EudraCT Number)
B1181003

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups, including a placebo group

PF-04382923
Experimental group
Treatment:
Biological: RN6G
Placebo
Placebo Comparator group
Treatment:
Biological: Placebo

Trial contacts and locations

83

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Data sourced from clinicaltrials.gov

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