search
Back to results

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

Primary Purpose

Age-Related Maculopathy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RN6G
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Maculopathy focused on measuring Phase 2, Advanced Dry Age-Related Macular Degeneration, Geographic Atrophy, RN6G

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Scottsdale Medical Imaging
  • Associated Retina Consultants, Ltd.
  • Premier Research Group Limited
  • Radiology Limited
  • Retina Associates
  • Reeds Compounding Pharmacy
  • Methodist Hospital of Southern California
  • Retina Institute of California
  • Mink Radiologic Imaging
  • Retina Vitreous Associates Medical Group
  • Retina-Vitreous Associates Medical Group
  • Northern California Retina Vitreous Associates
  • Valley Radiology Medical Associates, Inc.
  • Fairmount Pharmacy
  • Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)
  • Retinal Consultants Medical Group, Inc.
  • Leiter's Compounding Pharmacy
  • Cardiology Specialist of Orange County (ECG Evaluation Only)
  • Kenneth L. Nudleman M.D. (Neurology Exam Only)
  • Open Advantage MRI (Brain MRI Only)
  • Orange County Retina Medical Group
  • Quest Diagnostics Patient Service Center (Blood Draw Lab only)
  • Florida Eye Clinic
  • Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)
  • Mid Florida Imaging (MRI Only)
  • Center for Retina and Macular Disease
  • Medeye Associates
  • Open MRI & CT of South Miami
  • Retina Care Specialists, LLP
  • Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)
  • Sabates Eye Center Research Division
  • O'Brien Pharmacy (Drug Shipment Only)
  • Diagnostic Imaging (MRI Only)
  • Apothecary By Design
  • Charles Cathcart M.D.
  • Maine Eye Center
  • Intermed Diagnostic Imaging
  • Advanced Open MRI
  • Retina Vitreous Center
  • Shore Neurology, PA
  • King's Pharmacy
  • Zwager - Pesiri Radiology Group - MRI Exam Facility Only
  • Advanced Neurological Care, PC - Neurology Exam Facility Only
  • Ophthalmic Consultants of Long Island
  • Zwager - Pesiri Radiology Group - MRI Exam Facility Only
  • Lenox Hill Radiology/Regency Medical Imaging (MRI Only)
  • Macula Care, Pllc
  • Lenox Hill Radiology (MRI Only)
  • Zwager - Pesiri Radiology Group - MRI Exam Facility Only
  • Cardiology Consultants of Long Island, PC- Physical Exam Facility Only
  • Advanced Neurological Care, PC - Neurology Exam Facility Only
  • Cincinnati Eye Institute
  • Pro Scan Imaging
  • Associates in Ophthalmology, Ltd.
  • UPMC West Mifflin (MRI Only)
  • Hawthorne Pharmacy
  • InMed (MRI Facility)
  • Jay Markowitz, MD and Associates (Physical Exams Only)
  • Palmetto Retina Center
  • South Carolina Neurological Clinic (Neurological Exams Only)
  • Centennial Medical Center (MRI Only)
  • Tennessee Retina, P.C
  • Radiology Associates of North Texas
  • Innovative Infusion
  • Texas Retina Associates
  • Kevin E. Conner
  • Radiology Associates of North Texas
  • Brian B. Berger, MD, PA
  • Retina Research Center
  • River Ranch Radiology
  • Sleep Medicine Consultants
  • Specialty Compounding
  • Advanced Radiology Services
  • Edinburg Family Pharmacy
  • McAllen Advanced Medical Imaging
  • McAllen Surgical Specialty Center
  • Tommy Yee MD
  • Valley Retina Institute,P.A.
  • Weslaco Advanced Imaging
  • Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
  • Sound Prescriptions LLC
  • Orthopedic Physician Assoc. - MRI
  • Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04382923

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study
BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).
Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study
LL-BCVA is the measure of visual acuity under low light conditions.
Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
LL-BCVA is the measure of visual acuity under low light conditions.
Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
LL-BCVA is the measure of visual acuity under low light conditions.
Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).
Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Number of Participants With Treatment-Emergent Laboratory Abnormalities
Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.
Number of Participants With Abnormal Change From Baseline in Vital Signs
Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.
Number of Participants With Positive Anti-Drug Antibody (ADA)
The number of participants with positive ADA was to be summarized for each treatment arm.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Treatment-Related TEAEs
An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.
Maximum Observed Plasma Concentration (Cmax)
Minimum Observed Plasma Trough Concentration (Cmin)
Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)
Clearance at Steady State (CLss)
Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)
Accumulation Ratio (Rac) for AUCt
Plasma Population PK Parameters
Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.
Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.
Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.
Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.

Full Information

First Posted
April 11, 2012
Last Updated
February 16, 2016
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01577381
Brief Title
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Maculopathy
Keywords
Phase 2, Advanced Dry Age-Related Macular Degeneration, Geographic Atrophy, RN6G

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04382923
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
RN6G
Intervention Description
Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intravenous, 11 doses, 30 minute infusion
Primary Outcome Measure Information:
Title
Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309
Description
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).
Time Frame
Baseline and Day 309
Title
Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)
Description
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).
Time Frame
Baseline and Day 449
Secondary Outcome Measure Information:
Title
Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study
Description
BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study
Description
LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
Description
LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
Description
LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Description
Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Description
Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Description
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
Description
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Description
Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Description
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
Description
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Description
Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Description
The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Description
The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Time Frame
Baseline, Month 9, Month 12, Month 15, and End of Study
Title
Number of Participants With Treatment-Emergent Laboratory Abnormalities
Description
Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.
Time Frame
Day 85 and Day 169
Title
Number of Participants With Abnormal Change From Baseline in Vital Signs
Description
Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.
Time Frame
Screening, Days 28, 57, 85, 113, 141, and 169
Title
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
Description
Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.
Time Frame
Days 28, 57, 85, 113 and 169
Title
Number of Participants With Positive Anti-Drug Antibody (ADA)
Description
The number of participants with positive ADA was to be summarized for each treatment arm.
Time Frame
Day 57 and Day 169
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Days 28, 57, 85, 113, 141 and 169
Title
Number of Participants With Treatment-Related TEAEs
Description
An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.
Time Frame
Days 28, 57, 85, 113, 141 and 169
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Title
Minimum Observed Plasma Trough Concentration (Cmin)
Time Frame
Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Title
Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)
Time Frame
Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Title
Clearance at Steady State (CLss)
Description
Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)
Time Frame
Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Title
Accumulation Ratio (Rac) for AUCt
Time Frame
Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Title
Plasma Population PK Parameters
Description
Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.
Time Frame
Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
Title
Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
Description
Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.
Time Frame
Baseline, Day 449
Title
Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
Description
Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.
Time Frame
Baseline, Day 449
Title
Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
Description
Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.
Time Frame
Baseline, Day 449

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Medical Imaging
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Premier Research Group Limited
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Radiology Limited
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Retina Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Reeds Compounding Pharmacy
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85716
Country
United States
Facility Name
Methodist Hospital of Southern California
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Retina Institute of California
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Mink Radiologic Imaging
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Valley Radiology Medical Associates, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Fairmount Pharmacy
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
Leiter's Compounding Pharmacy
City
San Jose
State/Province
California
ZIP/Postal Code
95126
Country
United States
Facility Name
Cardiology Specialist of Orange County (ECG Evaluation Only)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Kenneth L. Nudleman M.D. (Neurology Exam Only)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Open Advantage MRI (Brain MRI Only)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Quest Diagnostics Patient Service Center (Blood Draw Lab only)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Mid Florida Imaging (MRI Only)
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Medeye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Open MRI & CT of South Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Retina Care Specialists, LLP
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Sabates Eye Center Research Division
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
O'Brien Pharmacy (Drug Shipment Only)
City
Mission
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Diagnostic Imaging (MRI Only)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Apothecary By Design
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Charles Cathcart M.D.
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
4102
Country
United States
Facility Name
Intermed Diagnostic Imaging
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Advanced Open MRI
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Retina Vitreous Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Shore Neurology, PA
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
King's Pharmacy
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Facility Name
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Advanced Neurological Care, PC - Neurology Exam Facility Only
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
City
Merrick
State/Province
New York
ZIP/Postal Code
11566
Country
United States
Facility Name
Lenox Hill Radiology/Regency Medical Imaging (MRI Only)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Macula Care, Pllc
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Radiology (MRI Only)
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Cardiology Consultants of Long Island, PC- Physical Exam Facility Only
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Advanced Neurological Care, PC - Neurology Exam Facility Only
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Pro Scan Imaging
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Associates in Ophthalmology, Ltd.
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
UPMC West Mifflin (MRI Only)
City
WestMifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Hawthorne Pharmacy
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
InMed (MRI Facility)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Jay Markowitz, MD and Associates (Physical Exams Only)
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
South Carolina Neurological Clinic (Neurological Exams Only)
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Centennial Medical Center (MRI Only)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Retina, P.C
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Radiology Associates of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Innovative Infusion
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Kevin E. Conner
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Radiology Associates of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76018
Country
United States
Facility Name
Brian B. Berger, MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
River Ranch Radiology
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Sleep Medicine Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Specialty Compounding
City
Cedar park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Advanced Radiology Services
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Edinburg Family Pharmacy
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
McAllen Advanced Medical Imaging
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
McAllen Surgical Specialty Center
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Tommy Yee MD
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Valley Retina Institute,P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Weslaco Advanced Imaging
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Sound Prescriptions LLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Orthopedic Physician Assoc. - MRI
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1181003&StudyName=Efficacy%2C%20Safety%20And%20Tolerability%20Study%20Of%20RN6G%20In%20Subjects%20With%20Geographic%20Atrophy%20Secondary%20to%20Age-related%20Macular%20Degeneration
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs