Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
- Conditions
- Age-Related MaculopathyEye DiseasesAge-Related MaculopathiesRetinal DegenerationMacular Degeneration
- Interventions
- Biological: RN6GBiological: Placebo
- Registration Number
- NCT00877032
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- Be of non-childbearing potential.
- Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
- BCVA of 20/320 or better in the worst eye.
- Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
- Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
- Diagnosis or recent history of clinically significant cerebrovascular disease.
- Uncontrolled hypertension.
- Uncontrolled Type 1 or Type 2 diabetes mellitus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Placebo - Arm 1 RN6G -
- Primary Outcome Measures
Name Time Method Incidence and Severity of Ocular Adverse Events (AEs) Baseline up to Day 168 AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.
Incidence and Severity of Systemic Adverse Events (AEs) Baseline up to Day 168 AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.
Maximum Observed Plasma Concentration (Cmax) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Participants who received RN6G were reported.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Participants who received RN6G were reported.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.
Volume of Distribution (Vd) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.
Plasma Terminal Half-life (t1/2) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.
Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165 AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.
Clearance (CL) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.
Mean Residence Time (MRT) of RN6G Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC\[0 to inf\])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC\[0 to inf\]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + \[(Ct\*tlast )/lamdaz \] + \[Ct/(lamdaz )\^2 \] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.
Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X) Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X) Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 Number of Participants With Anti-Drug Anti-body Baseline up to Day 168 Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.
Trial Locations
- Locations (19)
Dedicated Phase 1
🇺🇸Phoenix, Arizona, United States
Retinal Consultants of AZ
🇺🇸Phoenix, Arizona, United States
Insight Diagnostic Imaging Center
🇺🇸Phoenix, Arizona, United States
California Pharmacy and Compounding Center
🇺🇸Newport Beach, California, United States
Jonathan Rowe, MD
🇺🇸Kalamazoo, Michigan, United States
Ronald VanderLugt, MD
🇺🇸Kalamazoo, Michigan, United States
Specialty MRI
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Eye Care Associates, LC
🇺🇸Salt Lake City, Utah, United States
United Medical Imaging
🇺🇸Inglewood, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
EZ Pass Rx
🇺🇸Bountiful, Utah, United States
Jasper Clinic, Inc.
🇺🇸Kalamazoo, Michigan, United States
Amir Hedayati-Rad, MD
🇺🇸Glendale, California, United States
CEDRA Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Village Drive Imaging Center
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Western Neurological Associates
🇺🇸Salt Lake City, Utah, United States