Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00877032
First received: April 6, 2009
Last updated: March 20, 2015
Last verified: March 2015

April 6, 2009
March 20, 2015
April 2009
July 2011   (final data collection date for primary outcome measure)
  • Incidence and Severity of Ocular Adverse Events (AEs) [ Time Frame: Baseline up to Day 168 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline up to Day 168 ] [ Designated as safety issue: Yes ]
    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.
  • Incidence and severity of ocular adverse events [ Time Frame: Throughout the duration of the study ] [ Designated as safety issue: Yes ]
  • Incidence and severity of systemic adverse events [ Time Frame: Throughout the duration of the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00877032 on ClinicalTrials.gov Archive Site
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Participants who received RN6G were reported.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Participants who received RN6G were reported.
  • Volume of Distribution (Vd) of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Clearance (CL) of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Plasma Terminal Half-life (t1/2) of RN6G [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.
  • Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.
  • Number of Participants With Anti-Drug Anti-body [ Time Frame: Baseline up to Day 168 ] [ Designated as safety issue: Yes ]
    Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.
  • Levels of RN6G over time to determine pharamacokinetic parameters [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ] [ Designated as safety issue: No ]
  • Temporal changes in plasma levels of Aβ(1-X) (total Aβ) [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ] [ Designated as safety issue: No ]
  • Levels of antibodies against RN6G [ Time Frame: Day 0, 14, 28, 56, 84, 168 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
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)
The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
  • Biological: RN6G
    intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.
  • Biological: Placebo
    intravenous, single dose with experimental dose.
Experimental: Arm 1
Interventions:
  • Biological: RN6G
  • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877032
B1181001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP