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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of subjects meeting toxicity or intolerable dose criteria
    • Time Frame: Duration of the study
  • Incidence of treatment emergent adverse events (TEAEs) categorized by severity and causal relationship to study drug
    • Time Frame: Duration of the study
  • Incidence of ocular TEAEs identified by ocular examination, and spontaneously reported, categorized by severity and causal relationship to study drug
    • Time Frame: Duration of the study
  • Incidence of systemic TEAEs identified by physical examination, changes in vital signs, ECGs, clinical laboratory assessments, and spontaneously reported, categorized by severity and causal relationship to study drug
    • Time Frame: Duration of the study
  • Incidence of positive anti-drug-antibodies (ADA)
    • Time Frame: Duration of the study

Secondary Measures

  • Plasma RN6G concentrations will be measured and used in the determination of pharmacokinetic parameters after the first and after the sixth dose
    • Time Frame: Days 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304
  • Change from baseline (absolute and %) of plasma Aβ(1-x)(total), Aβ(1-40), and Aβ(1-42) concentrations
    • Time Frame: Days 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304
  • Change from baseline in clinical laboratory assessments, vital signs, and ECGs
    • Time Frame: Duration of the study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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