Clinical trial NCT00877032: Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Official title: A Phase I, Double-masked, Placebo-controlled Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of Single Escalating Doses Of Rn6g In Patients With Dry, Age-related Macular Degeneration (Amd)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Maculopathy
Age-Related Maculopathies
Eye Diseases
Retinal Degeneration
Macular Degeneration
Keywords: Phase 1
Dry Age Related Macular Degeneration
RN6G
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and Severity of Ocular Adverse Events (AEs)
timeFrame: Baseline up to Day 168
measure: Incidence and Severity of Systemic Adverse Events (AEs)
timeFrame: Baseline up to Day 168
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G
timeFrame: 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
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of RN6G
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G
timeFrame: 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
measure: Volume of Distribution (Vd) of RN6G
timeFrame: 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
measure: Clearance (CL) of RN6G
timeFrame: 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
measure: Mean Residence Time (MRT) of RN6G
timeFrame: 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
measure: Plasma Terminal Half-life (t1/2) of RN6G
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)
timeFrame: 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
measure: Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)
timeFrame: 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
measure: Number of Participants With Anti-Drug Anti-body
timeFrame: Baseline up to Day 168
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dedicated Phase 1
state: Arizona
city: Phoenix
country: United States
facility: Retinal Consultants of AZ
state: Arizona
city: Phoenix
country: United States
facility: Insight Diagnostic Imaging Center
state: Arizona
city: Glendale
country: United States
facility: Amir Hedayati-Rad, MD
state: California
city: Inglewood
country: United States
facility: United Medical Imaging
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: California Pharmacy and Compounding Center
state: California
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
city: Kalamazoo
country: United States
facility: Jonathan Rowe, MD
state: Michigan
city: Kalamazoo
country: United States
facility: Ronald VanderLugt, MD
state: Michigan
city: San Antonio
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Village Drive Imaging Center
state: Texas
city: San Antonio
country: United States
facility: Specialty MRI
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Bountiful
country: United States
facility: EZ Pass Rx
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Eye Care Associates, LC
state: Utah
city: Salt Lake City
country: United States
facility: Western Neurological Associates
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: