Age-Related MaculopathyPhase 2NCT01577381
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 2 study testing RN6G in people with Age-Related Maculopathy, run by Pfizer at 83 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Age-Related Maculopathy
- What is being tested?
- RN6G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 83 sitesUnited States
- Study dates
- Aug 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Florida Eye Clinic
Altamonte Springs, Florida, 32701
Maitland Avenue Urgent Care (Physical and Neurologic Exams Only)
Altamonte Springs, Florida, 32701
Mid Florida Imaging (MRI Only)
Altamonte Springs, Florida, 32714
Methodist Hospital of Southern California
Arcadia, California, 91007
Retina Institute of California
Arcadia, California, 91007
Radiology Associates of North Texas
Arlington, Texas, 76011
Innovative Infusion
Arlington, Texas, 76012
Texas Retina Associates
Arlington, Texas, 76012
Kevin E. Conner
Arlington, Texas, 76015
Radiology Associates of North Texas
Arlington, Texas, 76018
Brian B. Berger, MD, PA
Austin, Texas, 78705
Retina Research Center
Austin, Texas, 78705
River Ranch Radiology
Austin, Texas, 78705
Sleep Medicine Consultants
Austin, Texas, 78731
Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
Bellevue, Washington, 98004
Sound Prescriptions LLC
Bellevue, Washington, 98004
Mink Radiologic Imaging
Beverly Hills, California, 90211
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
King's Pharmacy
Brooklyn, New York, 11238
Specialty Compounding
Cedar Park, Texas, 78613
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Hawthorne Pharmacy
Columbia, South Carolina, 29201
InMed (MRI Facility)
Columbia, South Carolina, 29201
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
East Setauket, New York, 11733
Advanced Radiology Services
Edinburg, Texas, 78539
Edinburg Family Pharmacy
Edinburg, Texas, 78539
Center for Retina and Macular Disease
Lakeland, Florida, 33805
Sabates Eye Center Research Division
Leawood, Kansas, 66211
Advanced Neurological Care, PC - Neurology Exam Facility Only
Lynbrook, New York, 11563
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Pro Scan Imaging
Mason, Ohio, 45040
McAllen Advanced Medical Imaging
McAllen, Texas, 78501
McAllen Surgical Specialty Center
McAllen, Texas, 78503
Tommy Yee MD
McAllen, Texas, 78503
Valley Retina Institute,P.A.
McAllen, Texas, 78503
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
Merrick, New York, 11566
Medeye Associates
Miami, Florida, 33143
Open MRI & CT of South Miami
Miami, Florida, 33143
O'Brien Pharmacy (Drug Shipment Only)
Mission, Kansas, 66205
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Valley Radiology Medical Associates, Inc.
Mountain View, California, 94040
Centennial Medical Center (MRI Only)
Nashville, Tennessee, 37203
Tennessee Retina, P.C
Nashville, Tennessee, 37203
Lenox Hill Radiology/Regency Medical Imaging (MRI Only)
New York, New York, 10021
Macula Care, Pllc
New York, New York, 10021
Lenox Hill Radiology (MRI Only)
New York, New York, 10075
Diagnostic Imaging (MRI Only)
Overland Park, Kansas, 66211
Retina Care Specialists, LLP
Palm Beach Gardens, Florida, 33410
Fairmount Pharmacy
Pasadena, California, 91105
Scottsdale Medical Imaging
Phoenix, Arizona, 85016
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Premier Research Group Limited
Phoenix, Arizona, 85027
Zwager - Pesiri Radiology Group - MRI Exam Facility Only
Plainview, New York, 11803
Apothecary By Design
Portland, Maine, 04101
Charles Cathcart M.D.
Portland, Maine, 04101
Maine Eye Center
Portland, Maine, 4102
Cardiology Consultants of Long Island, PC- Physical Exam Facility Only
Rockville Centre, New York, 11570
Radiological Associates of Sacramento Medical Group, Inc. (MRI Imaging Only)
Roseville, California, 95661
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95841
Leiter's Compounding Pharmacy
San Jose, California, 95126
Cardiology Specialist of Orange County (ECG Evaluation Only)
Santa Ana, California, 92705
Kenneth L. Nudleman M.D. (Neurology Exam Only)
Santa Ana, California, 92705
Open Advantage MRI (Brain MRI Only)
Santa Ana, California, 92705
Orange County Retina Medical Group
Santa Ana, California, 92705
Quest Diagnostics Patient Service Center (Blood Draw Lab only)
Santa Ana, California, 92705
Orthopedic Physician Assoc. - MRI
Seattle, Washington, 98104
Proliance Surgeons, Inc. PS DBA Vitreo Retinal Associates
Seattle, Washington, 98104
Intermed Diagnostic Imaging
South Portland, Maine, 04106
Advanced Open MRI
Toms River, New Jersey, 08755
Retina Vitreous Center
Toms River, New Jersey, 08755
Shore Neurology, PA
Toms River, New Jersey, 08755
Radiology Limited
Tucson, Arizona, 85710
Retina Associates
Tucson, Arizona, 85710
Reeds Compounding Pharmacy
Tucson, Arizona, 85716
Advanced Neurological Care, PC - Neurology Exam Facility Only
Valley Stream, New York, 11570
Weslaco Advanced Imaging
Weslaco, Texas, 78596
Jay Markowitz, MD and Associates (Physical Exams Only)
West Columbia, South Carolina, 29169
Palmetto Retina Center
West Columbia, South Carolina, 29169
South Carolina Neurological Clinic (Neurological Exams Only)
West Columbia, South Carolina, 29169
Associates in Ophthalmology, Ltd.
West Mifflin, Pennsylvania, 15122
Premiere Research Institute At Palm Beach Neurology (MRI, Physical Exam, and Neurological Exam Only)
West Palm Beach, Florida, 33407
UPMC West Mifflin (MRI Only)
WestMifflin, Pennsylvania, 15122
About this study
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
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.
Read the 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.
- Conditions
- Age-Related Maculopathy
- Being tested
- RN6G, Placebo
- Keywords
- Phase 2, Advanced Dry Age-Related Macular Degeneration, Geographic Atrophy, RN6G
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN6GBiological
Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
PlaceboBiological
Intravenous, 11 doses, 30 minute infusion
| Study group | Role | What they receive |
|---|---|---|
| PF-04382923 | Experimental | Not described Receives: Biological: RN6G |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and Day 449
Secondary outcomes (31)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
LL-BCVA is the measure of visual acuity under low light conditions.
Measured: 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
LL-BCVA is the measure of visual acuity under low light conditions.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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).
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Baseline, Month 9, Month 12, Month 15, and End of Study
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.
Measured: Day 85 and Day 169
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.
Measured: Screening, Days 28, 57, 85, 113, 141, and 169
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.
Measured: Days 28, 57, 85, 113 and 169
Number of Participants With Positive Anti-Drug Antibody (ADA)
The number of participants with positive ADA was to be summarized for each treatment arm.
Measured: Day 57 and Day 169
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.
Measured: Days 28, 57, 85, 113, 141 and 169
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.
Measured: Days 28, 57, 85, 113, 141 and 169
Maximum Observed Plasma Concentration (Cmax)
Measured: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: 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)
Measured: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
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)
Measured: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Accumulation Ratio (Rac) for AUCt
Measured: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
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.
Measured: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
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.
Measured: Baseline, Day 449
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.
Measured: Baseline, Day 449
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.
Measured: Baseline, Day 449
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionOct 2013
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related MaculopathyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577381
- Sponsor's protocol ID
- B1181003
- Other IDs
- 2012-000823-42
- Status last verified
- Feb 2016
- First submitted
- 11 Apr 2012
- Last updated
- 16 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01577381
- Acronym / sponsor ID
- B1181003
- Conditions
- Age-Related Maculopathy
- Keywords
- Phase 2, Advanced Dry Age-Related Macular Degeneration, Geographic Atrophy, RN6G
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Posted 16 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04382923 | Experimental | Biological: RN6G |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RN6GIntravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg | Biological | PF-04382923 |
| PlaceboIntravenous, 11 doses, 30 minute infusion | Biological | Placebo |
Primary outcome
Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309
Time frame: 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)
Time frame: 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).
31 secondary outcomes
Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Time frame: Baseline, Month 9, Month 12, Month 15, and End of Study
Number of Participants With Treatment-Emergent Laboratory Abnormalities
Time frame: Day 85 and Day 169
Number of Participants With Abnormal Change From Baseline in Vital Signs
Time frame: Screening, Days 28, 57, 85, 113, 141, and 169
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
Time frame: Days 28, 57, 85, 113 and 169
Number of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Day 57 and Day 169
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
Time frame: Days 28, 57, 85, 113, 141 and 169
Number of Participants With Treatment-Related TEAEs
Time frame: Days 28, 57, 85, 113, 141 and 169
Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: 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)
Time frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Clearance at Steady State (CLss)
Time frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Accumulation Ratio (Rac) for AUCt
Time frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Plasma Population PK Parameters
Time frame: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
Time frame: Baseline, Day 449
Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
Time frame: Baseline, Day 449
Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
Time frame: Baseline, Day 449
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RN6G in people with Age-Related Maculopathy, run by Pfizer at 83 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309 (time frame: Baseline and Day 309). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.