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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00877032
Other study ID # B1181001
Secondary ID
Status Completed
Phase Phase 1
First received April 6, 2009
Last updated March 20, 2015
Start date April 2009
Est. completion date July 2011

Study information

Verified date March 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
RN6G
intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.
Placebo
intravenous, single dose with experimental dose.

Locations

Country Name City State
United States EZ Pass Rx Bountiful Utah
United States Amir Hedayati-Rad, MD Glendale California
United States United Medical Imaging Inglewood California
United States United Medical Research Institute Inglewood California
United States Jasper Clinic, Inc. Kalamazoo Michigan
United States Jonathan Rowe, MD Kalamazoo Michigan
United States Ronald VanderLugt, MD Kalamazoo Michigan
United States California Pharmacy and Compounding Center Newport Beach California
United States Dedicated Phase 1 Phoenix Arizona
United States Insight Diagnostic Imaging Center Phoenix Arizona
United States Retinal Consultants of AZ Phoenix Arizona
United States Lifetree Clinical Research Salt Lake City Utah
United States Rocky Mountain Eye Care Associates, LC Salt Lake City Utah
United States Western Neurological Associates Salt Lake City Utah
United States CEDRA Clinical Research, LLC San Antonio Texas
United States Medical Center Ophthalmology Associates San Antonio Texas
United States Medical Center Ophthalmology Associates San Antonio Texas
United States Retinal Consultants of San Antonio San Antonio Texas
United States Specialty MRI San Antonio Texas
United States Village Drive Imaging Center San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Ocular Adverse Events (AEs) 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. Baseline up to Day 168 Yes
Primary Incidence and Severity of Systemic Adverse Events (AEs) 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. Baseline up to Day 168 Yes
Secondary Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G 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. 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 No
Secondary Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G 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. 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 No
Secondary Maximum Observed Plasma Concentration (Cmax) of RN6G Participants who received RN6G were reported. 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 No
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G Participants who received RN6G were reported. 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 No
Secondary Volume of Distribution (Vd) of RN6G 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. 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 No
Secondary Clearance (CL) of RN6G 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. 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 No
Secondary Mean Residence Time (MRT) of RN6G 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. 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 No
Secondary Plasma Terminal Half-life (t1/2) of RN6G Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported. 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 No
Secondary 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 No
Secondary 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 No
Secondary Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165. 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 No
Secondary Number of Participants With Anti-Drug Anti-body Participants tested positive for anti-drug anti-body on at least one or more occasions were reported. Baseline up to Day 168 Yes
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