Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
- Conditions
- Age-Related Maculopathy
- Interventions
- Biological: PlaceboBiological: RN6G
- Registration Number
- NCT01577381
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - PF-04382923 RN6G -
- Primary Outcome Measures
Name Time Method Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309 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) 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 Outcome Measures
Name Time Method 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 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).
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 LL-BCVA is the measure of visual acuity under low light conditions.
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 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 Baseline, Month 9, Month 12, Month 15, 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 Baseline, Month 9, Month 12, Month 15, 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 Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Days 28, 57, 85, 113 and 169 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) Day 57 and Day 169 The number of participants with positive ADA was to be summarized for each treatment arm.
Number of Participants With Treatment-Related TEAEs Days 28, 57, 85, 113, 141 and 169 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.
Clearance at Steady State (CLss) Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)
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 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.
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 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 Baseline, Month 9, Month 12, Month 15, 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).
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 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 Baseline, Month 9, Month 12, Month 15, and End of Study LL-BCVA is the measure of visual acuity under low light conditions.
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 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 Speed at 9, 12, 15 Months and End of Study Baseline, Month 9, Month 12, Month 15, 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 Baseline, Month 9, Month 12, Month 15, 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.
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 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.
Number of Participants With Abnormal Change From Baseline in Vital Signs Screening, Days 28, 57, 85, 113, 141, and 169 Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness Days 28, 57, 85, 113, 141 and 169 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.
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 Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
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 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 Day 85 and Day 169 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.
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 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 Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449) Baseline, Day 449 Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.
Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449) Baseline, Day 449 Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.
Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449) Baseline, Day 449 Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.
Trial Locations
- Locations (78)
Apothecary By Design
🇺🇸Portland, Maine, United States
Cardiology Consultants of Long Island, PC- Physical Exam Facility Only
🇺🇸Rockville Centre, New York, United States
South Carolina Neurological Clinic (Neurological Exams Only)
🇺🇸West Columbia, South Carolina, United States
Charles Cathcart M.D.
🇺🇸Portland, Maine, United States
Radiology Limited
🇺🇸Tucson, Arizona, United States
Orthopedic Physician Assoc. - MRI
🇺🇸Seattle, Washington, United States
Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
🇺🇸Seattle, Washington, United States
Open MRI & CT of South Miami
🇺🇸Miami, Florida, United States
Diagnostic Imaging (MRI Only)
🇺🇸Overland Park, Kansas, United States
O'Brien Pharmacy (Drug Shipment Only)
🇺🇸Mission, Kansas, United States
Sabates Eye Center Research Division
🇺🇸Leawood, Kansas, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Scottsdale Medical Imaging
🇺🇸Phoenix, Arizona, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Premier Research Group Limited
🇺🇸Phoenix, Arizona, United States
Centennial Medical Center (MRI Only)
🇺🇸Nashville, Tennessee, United States
Tennessee Retina, P.C
🇺🇸Nashville, Tennessee, United States
Methodist Hospital of Southern California
🇺🇸Arcadia, California, United States
Reeds Compounding Pharmacy
🇺🇸Tucson, Arizona, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Mink Radiologic Imaging
🇺🇸Beverly Hills, California, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Institute of California
🇺🇸Arcadia, California, United States
Valley Radiology Medical Associates, Inc.
🇺🇸Mountain View, California, United States
Fairmount Pharmacy
🇺🇸Pasadena, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)
🇺🇸Roseville, California, United States
Leiter's Compounding Pharmacy
🇺🇸San Jose, California, United States
Florida Eye Clinic
🇺🇸Altamonte Springs, Florida, United States
Mid Florida Imaging (MRI Only)
🇺🇸Altamonte Springs, Florida, United States
Quest Diagnostics Patient Service Center (Blood Draw Lab only)
🇺🇸Santa Ana, California, United States
Center for Retina and Macular Disease
🇺🇸Lakeland, Florida, United States
Medeye Associates
🇺🇸Miami, Florida, United States
Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)
🇺🇸Altamonte Springs, Florida, United States
Retina Care Specialists, LLP
🇺🇸Palm Beach Gardens, Florida, United States
Intermed Diagnostic Imaging
🇺🇸South Portland, Maine, United States
Advanced Open MRI
🇺🇸Toms River, New Jersey, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
Retina Vitreous Center
🇺🇸Toms River, New Jersey, United States
Shore Neurology, PA
🇺🇸Toms River, New Jersey, United States
Advanced Neurological Care, PC - Neurology Exam Facility Only
🇺🇸Valley Stream, New York, United States
Lenox Hill Radiology (MRI Only)
🇺🇸New York, New York, United States
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
🇺🇸Plainview, New York, United States
Lenox Hill Radiology/Regency Medical Imaging (MRI Only)
🇺🇸New York, New York, United States
Macula Care, Pllc
🇺🇸New York, New York, United States
King's Pharmacy
🇺🇸Brooklyn, New York, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Pro Scan Imaging
🇺🇸Mason, Ohio, United States
UPMC West Mifflin (MRI Only)
🇺🇸WestMifflin, Pennsylvania, United States
Associates in Ophthalmology, Ltd.
🇺🇸West Mifflin, Pennsylvania, United States
Hawthorne Pharmacy
🇺🇸Columbia, South Carolina, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
InMed (MRI Facility)
🇺🇸Columbia, South Carolina, United States
Jay Markowitz, MD and Associates (Physical Exams Only)
🇺🇸West Columbia, South Carolina, United States
Radiology Associates of North Texas
🇺🇸Arlington, Texas, United States
Innovative Infusion
🇺🇸Arlington, Texas, United States
Kevin E. Conner
🇺🇸Arlington, Texas, United States
River Ranch Radiology
🇺🇸Austin, Texas, United States
Specialty Compounding
🇺🇸Cedar park, Texas, United States
Brian B. Berger, MD, PA
🇺🇸Austin, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Sleep Medicine Consultants
🇺🇸Austin, Texas, United States
Advanced Radiology Services
🇺🇸Edinburg, Texas, United States
Tommy Yee MD
🇺🇸McAllen, Texas, United States
Edinburg Family Pharmacy
🇺🇸Edinburg, Texas, United States
Valley Retina Institute,P.A.
🇺🇸McAllen, Texas, United States
McAllen Advanced Medical Imaging
🇺🇸McAllen, Texas, United States
McAllen Surgical Specialty Center
🇺🇸McAllen, Texas, United States
Weslaco Advanced Imaging
🇺🇸Weslaco, Texas, United States
Sound Prescriptions LLC
🇺🇸Bellevue, Washington, United States
Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)
🇺🇸West Palm Beach, Florida, United States
Cardiology Specialist of Orange County (ECG Evaluation Only)
🇺🇸Santa Ana, California, United States
Open Advantage MRI (Brain MRI Only)
🇺🇸Santa Ana, California, United States
Kenneth L. Nudleman M.D. (Neurology Exam Only)
🇺🇸Santa Ana, California, United States
Orange County Retina Medical Group
🇺🇸Santa Ana, California, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Retina Associates
🇺🇸Tucson, Arizona, United States