Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

NCT00877032 | Completed Phase 1 Results

• 1 other identifier: B1181001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration

Keywords

Phase 1; Dry Age Related Macular Degeneration; RN6G

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

Biological: RN6G; Biological: Placebo

Interventions

RN6G BIOLOGICAL

intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.

Arm 1

Placebo BIOLOGICAL

intravenous, single dose with experimental dose.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (20)

Dedicated Phase 1

Phoenix, Arizona, 85013, United States

Location

Retinal Consultants of AZ

Phoenix, Arizona, 85014, United States

Location

Insight Diagnostic Imaging Center

Phoenix, Arizona, 85015, United States

Location

Amir Hedayati-Rad, MD

Glendale, California, 91206, United States

Location

United Medical Imaging

Inglewood, California, 90301, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

California Pharmacy and Compounding Center

Newport Beach, California, 92660, United States

Location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

Jonathan Rowe, MD

Kalamazoo, Michigan, 49048, United States

Location

Ronald VanderLugt, MD

Kalamazoo, Michigan, 49048, United States

Location

CEDRA Clinical Research, LLC

San Antonio, Texas, 78217, United States

Location

Village Drive Imaging Center

San Antonio, Texas, 78217, United States

Location

Specialty MRI

San Antonio, Texas, 78229, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78233, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

EZ Pass Rx

Bountiful, Utah, 84010, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Rocky Mountain Eye Care Associates, LC

Salt Lake City, Utah, 84107, United States

Location

Western Neurological Associates

Salt Lake City, Utah, 84124, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases; Retinal Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases, Hereditary

Limitations and Caveats

Results for pharmacodynamic parameters \[Cmax, Tmax and AUC (0-65d) of A beta(1-X)\], are presented as absolute values at specified time points and not as change from baseline as planned.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 31, 2015
• Results First Posted: March 31, 2015

Record last verified: 2015-03

Locations

US (20)