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

NCT ID: NCT01577381

Last Updated: 2016-03-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Age-Related Maculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04382923

Group Type EXPERIMENTAL

RN6G

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Intravenous, 11 doses, 30 minute infusion

Interventions

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RN6G

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

Intervention Type BIOLOGICAL

Placebo

Intravenous, 11 doses, 30 minute infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Scottsdale Medical Imaging

Phoenix, Arizona, United States

Site Status

Associated Retina Consultants, Ltd.

Phoenix, Arizona, United States

Site Status

Premier Research Group Limited

Phoenix, Arizona, United States

Site Status

Radiology Limited

Tucson, Arizona, United States

Site Status

Retina Associates

Tucson, Arizona, United States

Site Status

Reeds Compounding Pharmacy

Tucson, Arizona, United States

Site Status

Methodist Hospital of Southern California

Arcadia, California, United States

Site Status

Retina Institute of California

Arcadia, California, United States

Site Status

Mink Radiologic Imaging

Beverly Hills, California, United States

Site Status

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

Valley Radiology Medical Associates, Inc.

Mountain View, California, United States

Site Status

Fairmount Pharmacy

Pasadena, California, United States

Site Status

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

Roseville, California, United States

Site Status

Retinal Consultants Medical Group, Inc.

Sacramento, California, United States

Site Status

Leiter's Compounding Pharmacy

San Jose, California, United States

Site Status

Cardiology Specialist of Orange County (ECG Evaluation Only)

Santa Ana, California, United States

Site Status

Kenneth L. Nudleman M.D. (Neurology Exam Only)

Santa Ana, California, United States

Site Status

Open Advantage MRI (Brain MRI Only)

Santa Ana, California, United States

Site Status

Orange County Retina Medical Group

Santa Ana, California, United States

Site Status

Quest Diagnostics Patient Service Center (Blood Draw Lab only)

Santa Ana, California, United States

Site Status

Florida Eye Clinic

Altamonte Springs, Florida, United States

Site Status

Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)

Altamonte Springs, Florida, United States

Site Status

Mid Florida Imaging (MRI Only)

Altamonte Springs, Florida, United States

Site Status

Center for Retina and Macular Disease

Lakeland, Florida, United States

Site Status

Medeye Associates

Miami, Florida, United States

Site Status

Open MRI & CT of South Miami

Miami, Florida, United States

Site Status

Retina Care Specialists, LLP

Palm Beach Gardens, Florida, United States

Site Status

Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)

West Palm Beach, Florida, United States

Site Status

Sabates Eye Center Research Division

Leawood, Kansas, United States

Site Status

O'Brien Pharmacy (Drug Shipment Only)

Mission, Kansas, United States

Site Status

Diagnostic Imaging (MRI Only)

Overland Park, Kansas, United States

Site Status

Apothecary By Design

Portland, Maine, United States

Site Status

Charles Cathcart M.D.

Portland, Maine, United States

Site Status

Maine Eye Center

Portland, Maine, United States

Site Status

Intermed Diagnostic Imaging

South Portland, Maine, United States

Site Status

Advanced Open MRI

Toms River, New Jersey, United States

Site Status

Retina Vitreous Center

Toms River, New Jersey, United States

Site Status

Shore Neurology, PA

Toms River, New Jersey, United States

Site Status

King's Pharmacy

Brooklyn, New York, United States

Site Status

Zwager - Pesiri Radiology Group - MRI Exam Facility Only

East Setauket, New York, United States

Site Status

Advanced Neurological Care, PC - Neurology Exam Facility Only

Lynbrook, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Site Status

Zwager - Pesiri Radiology Group - MRI Exam Facility Only

Merrick, New York, United States

Site Status

Lenox Hill Radiology/Regency Medical Imaging (MRI Only)

New York, New York, United States

Site Status

Macula Care, Pllc

New York, New York, United States

Site Status

Lenox Hill Radiology (MRI Only)

New York, New York, United States

Site Status

Zwager - Pesiri Radiology Group - MRI Exam Facility Only

Plainview, New York, United States

Site Status

Cardiology Consultants of Long Island, PC- Physical Exam Facility Only

Rockville Centre, New York, United States

Site Status

Advanced Neurological Care, PC - Neurology Exam Facility Only

Valley Stream, New York, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Pro Scan Imaging

Mason, Ohio, United States

Site Status

Associates in Ophthalmology, Ltd.

West Mifflin, Pennsylvania, United States

Site Status

UPMC West Mifflin (MRI Only)

WestMifflin, Pennsylvania, United States

Site Status

Hawthorne Pharmacy

Columbia, South Carolina, United States

Site Status

InMed (MRI Facility)

Columbia, South Carolina, United States

Site Status

Jay Markowitz, MD and Associates (Physical Exams Only)

West Columbia, South Carolina, United States

Site Status

Palmetto Retina Center

West Columbia, South Carolina, United States

Site Status

South Carolina Neurological Clinic (Neurological Exams Only)

West Columbia, South Carolina, United States

Site Status

Centennial Medical Center (MRI Only)

Nashville, Tennessee, United States

Site Status

Tennessee Retina, P.C

Nashville, Tennessee, United States

Site Status

Radiology Associates of North Texas

Arlington, Texas, United States

Site Status

Innovative Infusion

Arlington, Texas, United States

Site Status

Texas Retina Associates

Arlington, Texas, United States

Site Status

Kevin E. Conner

Arlington, Texas, United States

Site Status

Radiology Associates of North Texas

Arlington, Texas, United States

Site Status

Brian B. Berger, MD, PA

Austin, Texas, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

River Ranch Radiology

Austin, Texas, United States

Site Status

Sleep Medicine Consultants

Austin, Texas, United States

Site Status

Specialty Compounding

Cedar Park, Texas, United States

Site Status

Advanced Radiology Services

Edinburg, Texas, United States

Site Status

Edinburg Family Pharmacy

Edinburg, Texas, United States

Site Status

McAllen Advanced Medical Imaging

McAllen, Texas, United States

Site Status

McAllen Surgical Specialty Center

McAllen, Texas, United States

Site Status

Tommy Yee MD

McAllen, Texas, United States

Site Status

Valley Retina Institute,P.A.

McAllen, Texas, United States

Site Status

Weslaco Advanced Imaging

Weslaco, Texas, United States

Site Status

Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates

Bellevue, Washington, United States

Site Status

Sound Prescriptions LLC

Bellevue, Washington, United States

Site Status

Orthopedic Physician Assoc. - MRI

Seattle, Washington, United States

Site Status

Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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2012-000823-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1181003

Identifier Type: -

Identifier Source: org_study_id

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