NCT01577381|TerminatedPhase 2ResultsDMC

Study Stopped

See termination reason in detailed description.

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

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

Pfizer ClinicalTrials.gov

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2 other identifiers

B11810032012-000823-42

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2012

StartedAug 2012

CompletionOct 2013

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach

1 country

83 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

April 11, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2016

Completed

Last Updated

March 16, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

April 11, 2012

Results QC Date

December 9, 2015

Last Update Submit

February 16, 2016

Conditions

Age-Related Maculopathy

Keywords

Phase 2Advanced Dry Age-Related Macular DegenerationGeographic AtrophyRN6G

Outcome Measures

Primary Outcomes (2)

Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at 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).
Baseline and Day 309
Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)
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).
Baseline and Day 449

Secondary Outcomes (31)

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
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
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 Letters at 9, 12, 15 Months and End of Study
Baseline, Month 9, Month 12, Month 15, and End of Study
+26 more secondary outcomes

Study Arms (2)

PF-04382923

EXPERIMENTAL

Biological: RN6G

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

RN6GBIOLOGICAL

Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg

PF-04382923

PlaceboBIOLOGICAL

Intravenous, 11 doses, 30 minute infusion

Placebo

Eligibility Criteria

Age60 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (83)

Scottsdale Medical Imaging

Phoenix, Arizona, 85016, United States

Location

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Premier Research Group Limited

Phoenix, Arizona, 85027, United States

Location

Radiology Limited

Tucson, Arizona, 85710, United States

Location

Retina Associates

Tucson, Arizona, 85710, United States

Location

Reeds Compounding Pharmacy

Tucson, Arizona, 85716, United States

Location

Methodist Hospital of Southern California

Arcadia, California, 91007, United States

Location

Retina Institute of California

Arcadia, California, 91007, United States

Location

Mink Radiologic Imaging

Beverly Hills, California, 90211, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Valley Radiology Medical Associates, Inc.

Mountain View, California, 94040, United States

Location

Fairmount Pharmacy

Pasadena, California, 91105, United States

Location

Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)

Roseville, California, 95661, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95841, United States

Location

Leiter's Compounding Pharmacy

San Jose, California, 95126, United States

Location

Cardiology Specialist of Orange County (ECG Evaluation Only)