Clinical trial NCT01577381: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Maculopathy
Keywords: Phase 2
Advanced Dry Age-Related Macular Degeneration
Geographic Atrophy
RN6G
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309
timeFrame: Baseline and Day 309
measure: Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)
timeFrame: Baseline and Day 449
Secondary outcomes:
measure: Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
timeFrame: Baseline, Month 9, Month 12, Month 15, and End of Study
measure: Number of Participants With Treatment-Emergent Laboratory Abnormalities
timeFrame: Day 85 and Day 169
measure: Number of Participants With Abnormal Change From Baseline in Vital Signs
timeFrame: Screening, Days 28, 57, 85, 113, 141, and 169
measure: Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
timeFrame: Days 28, 57, 85, 113 and 169
measure: Number of Participants With Positive Anti-Drug Antibody (ADA)
timeFrame: Day 57 and Day 169
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
timeFrame: Days 28, 57, 85, 113, 141 and 169
measure: Number of Participants With Treatment-Related TEAEs
timeFrame: Days 28, 57, 85, 113, 141 and 169
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
measure: Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)
timeFrame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
measure: Clearance at Steady State (CLss)
timeFrame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
measure: Accumulation Ratio (Rac) for AUCt
timeFrame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
measure: Plasma Population PK Parameters
timeFrame: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
measure: Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
timeFrame: Baseline, Day 449
measure: Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
timeFrame: Baseline, Day 449
measure: Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
timeFrame: Baseline, Day 449
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Premier Research Group Limited
state: Arizona
city: Tucson
country: United States
facility: Radiology Limited
state: Arizona
city: Tucson
country: United States
facility: Retina Associates
state: Arizona
city: Tucson
country: United States
facility: Reeds Compounding Pharmacy
state: Arizona
city: Arcadia
country: United States
facility: Methodist Hospital of Southern California
state: California
city: Arcadia
country: United States
facility: Retina Institute of California
state: California
city: Beverly Hills
country: United States
facility: Mink Radiologic Imaging
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Mountain View
country: United States
facility: Valley Radiology Medical Associates, Inc.
state: California
city: Pasadena
country: United States
facility: Fairmount Pharmacy
state: California
city: Roseville
country: United States
facility: Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Leiter's Compounding Pharmacy
state: California
city: Santa Ana
country: United States
facility: Cardiology Specialist of Orange County (ECG Evaluation Only)
state: California
city: Santa Ana
country: United States
facility: Kenneth L. Nudleman M.D. (Neurology Exam Only)
state: California
city: Santa Ana
country: United States
facility: Open Advantage MRI (Brain MRI Only)
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Ana
country: United States
facility: Quest Diagnostics Patient Service Center (Blood Draw Lab only)
state: California
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic
state: Florida
city: Altamonte Springs
country: United States
facility: Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)
state: Florida
city: Altamonte Springs
country: United States
facility: Mid Florida Imaging (MRI Only)
state: Florida
city: Lakeland
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Miami
country: United States
facility: Medeye Associates
state: Florida
city: Miami
country: United States
facility: Open MRI & CT of South Miami
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists, LLP
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)
state: Florida
city: Leawood
country: United States
facility: Sabates Eye Center Research Division
state: Kansas
city: Mission
country: United States
facility: O'Brien Pharmacy (Drug Shipment Only)
state: Kansas
city: Overland Park
country: United States
facility: Diagnostic Imaging (MRI Only)
state: Kansas
city: Portland
country: United States
facility: Apothecary By Design
state: Maine
city: Portland
country: United States
facility: Charles Cathcart M.D.
state: Maine
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: South Portland
country: United States
facility: Intermed Diagnostic Imaging
state: Maine
city: Toms River
country: United States
facility: Advanced Open MRI
state: New Jersey
city: Toms River
country: United States
facility: Retina Vitreous Center
state: New Jersey
city: Toms River
country: United States
facility: Shore Neurology, PA
state: New Jersey
city: Brooklyn
country: United States
facility: King's Pharmacy
state: New York
city: East Setauket
country: United States
facility: Zwager - Pesiri Radiology Group - MRI Exam Facility Only
state: New York
city: Lynbrook
country: United States
facility: Advanced Neurological Care, PC - Neurology Exam Facility Only
state: New York
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Merrick
country: United States
facility: Zwager - Pesiri Radiology Group - MRI Exam Facility Only
state: New York
city: New York
country: United States
facility: Lenox Hill Radiology/Regency Medical Imaging (MRI Only)
state: New York
city: New York
country: United States
facility: Macula Care, Pllc
state: New York
city: New York
country: United States
facility: Lenox Hill Radiology (MRI Only)
state: New York
city: Plainview
country: United States
facility: Zwager - Pesiri Radiology Group - MRI Exam Facility Only
state: New York
city: Rockville Centre
country: United States
facility: Cardiology Consultants of Long Island, PC- Physical Exam Facility Only
state: New York
city: Valley Stream
country: United States
facility: Advanced Neurological Care, PC - Neurology Exam Facility Only
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Mason
country: United States
facility: Pro Scan Imaging
state: Ohio
city: West Mifflin
country: United States
facility: Associates in Ophthalmology, Ltd.
state: Pennsylvania
city: WestMifflin
country: United States
facility: UPMC West Mifflin (MRI Only)
state: Pennsylvania
city: Columbia
country: United States
facility: Hawthorne Pharmacy
state: South Carolina
city: Columbia
country: United States
facility: InMed (MRI Facility)
state: South Carolina
city: West Columbia
country: United States
facility: Jay Markowitz, MD and Associates (Physical Exams Only)
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: West Columbia
country: United States
facility: South Carolina Neurological Clinic (Neurological Exams Only)
state: South Carolina
city: Nashville
country: United States
facility: Centennial Medical Center (MRI Only)
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, P.C
state: Tennessee
city: Arlington
country: United States
facility: Radiology Associates of North Texas
state: Texas
city: Arlington
country: United States
facility: Innovative Infusion
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Arlington
country: United States
facility: Kevin E. Conner
state: Texas
city: Arlington
country: United States
facility: Radiology Associates of North Texas
state: Texas
city: Austin
country: United States
facility: Brian B. Berger, MD, PA
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Austin
country: United States
facility: River Ranch Radiology
state: Texas
city: Austin
country: United States
facility: Sleep Medicine Consultants
state: Texas
city: Cedar park
country: United States
facility: Specialty Compounding
state: Texas
city: Edinburg
country: United States
facility: Advanced Radiology Services
state: Texas
city: Edinburg
country: United States
facility: Edinburg Family Pharmacy
state: Texas
city: McAllen
country: United States
facility: McAllen Advanced Medical Imaging
state: Texas
city: McAllen
country: United States
facility: McAllen Surgical Specialty Center
state: Texas
city: McAllen
country: United States
facility: Tommy Yee MD
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute,P.A.
state: Texas
city: Weslaco
country: United States
facility: Weslaco Advanced Imaging
state: Texas
city: Bellevue
country: United States
facility: Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
state: Washington
city: Bellevue
country: United States
facility: Sound Prescriptions LLC
state: Washington
city: Seattle
country: United States
facility: Orthopedic Physician Assoc. - MRI
state: Washington
city: Seattle
country: United States
facility: Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: