Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
A PHASE 1, DOUBLE-MASKED, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MULTIPLE ESCALATING DOSAGES OF RN6G (PF-04382923) IN SUBJECTS WITH ADVANCED DRY, AGE-RELATED MACULAR DEGENERATION (AMD) INCLUDING GEOGRAPHIC ATROPHY
1 other identifier
interventional
24
1 country
24
Brief Summary
The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2010
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2009
CompletedFirst Posted
Study publicly available on registry
October 29, 2009
CompletedStudy Start
First participant enrolled
August 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2013
CompletedResults Posted
Study results publicly available
May 12, 2022
CompletedMay 12, 2022
May 1, 2022
2.6 years
October 28, 2009
November 9, 2021
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Participants With Toxicity or Intolerable Dose Criteria
The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter.
Baseline up to Day 304/End of Treatment (ET)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Baseline up to Day 304/ET
Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.
Baseline up to Day 304/ET
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Baseline up to Day 304/ET
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.
Baseline up to Day 304/ET
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Baseline up to Day 304/ET
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.
Baseline up to Day 304/ET
Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab)
The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples.
Baseline up to Day 304/ET
Secondary Outcomes (36)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140
Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Plasma Concentration (Css) at Steady State of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
- +31 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Be of non-child bearing potential
- Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement
- BCVA of 20/50 or better in the study eye
You may not qualify if:
- Evidence of ocular disease other than advanced AMD or GA in the study eye
- History or diagnosis of exudative (wet) AMD, 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
- Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (24)
Retinal Diagnostic Center
Campbell, California, 95008, United States
American Institute of Research (Administrative Only)
Los Gatos, California, 95032, United States
Neurology Center Rai Kumar
San Jose, California, 95116, United States
Harmeet Sachdev, MD, FAAN
San Jose, California, 95124, United States
Santa Clara Drug
San Jose, California, 95128, United States
Retina Associates of Florida, PA
Tampa, Florida, 33609, United States
Hoye's Pharmacy
Tampa, Florida, 33611, United States
Ranjit K. Sethi, MD, PC
Augusta, Georgia, 30901, United States
Clinical Specialists, LLC
Augusta, Georgia, 30907, United States
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of Rochester
Rochester, New York, 14642, United States
Hawthorne Pharmacy
West Columbia, South Carolina, 29169, United States
Jay Markowitz and Associates
West Columbia, South Carolina, 29169, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169, United States
South Carolina Neurological
West Columbia, South Carolina, 29169, United States
National Central Pharmacy
Abilene, Texas, 79605, United States
Abilene Surgery Center
Abilene, Texas, 79606, United States
Heart and Vascular Institute
Abilene, Texas, 79606, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Brian B. Berger, MD, PA
Austin, Texas, 78705, United States
Retina Research Center, PLLC
Austin, Texas, 78705, United States
Sleep Medicine Consultants
Austin, Texas, 78731, United States
Specialty Compounding
Cedar Park, Texas, 78613, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2009
First Posted
October 29, 2009
Study Start
August 5, 2010
Primary Completion
March 5, 2013
Study Completion
April 19, 2013
Last Updated
May 12, 2022
Results First Posted
May 12, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.