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

Pfizer78 sites in 1 country10 target enrollmentAugust 2012

ConditionsAge-Related Maculopathy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Age-Related Maculopathy
Sponsor: Pfizer
Enrollment: 10
Locations: 78
Primary Endpoint: Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

October 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309

Time Frame: Baseline and Day 309

GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).

Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)

Time Frame: Baseline and Day 449

GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).

Secondary Outcomes

Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings(Days 28, 57, 85, 113 and 169)
Number of Participants With Positive Anti-Drug Antibody (ADA)(Day 57 and Day 169)
Number of Participants With Treatment-Related TEAEs(Days 28, 57, 85, 113, 141 and 169)
Clearance at Steady State (CLss)(Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449)
Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Accumulation Ratio (Rac) for AUCt(Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449)
Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Number of Participants With Abnormal Change From Baseline in Vital Signs(Screening, Days 28, 57, 85, 113, 141, and 169)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness(Days 28, 57, 85, 113, 141 and 169)
Minimum Observed Plasma Trough Concentration (Cmin)(Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449)
Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study(Baseline, Month 9, Month 12, Month 15, and End of Study)
Number of Participants With Treatment-Emergent Laboratory Abnormalities(Day 85 and Day 169)
Maximum Observed Plasma Concentration (Cmax)(Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449)
Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)(Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449)
Plasma Population PK Parameters(Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449)
Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)(Baseline, Day 449)
Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)(Baseline, Day 449)
Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)(Baseline, Day 449)