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Trial record 1 of 1 for:    NCT00877032
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Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00877032
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Results First Submitted Date  ICMJE March 20, 2015
Results First Posted Date  ICMJE March 31, 2015
Last Update Posted Date March 31, 2015
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
  • Incidence and Severity of Ocular Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
  • Incidence and severity of ocular adverse events [ Time Frame: Throughout the duration of the study ]
  • Incidence and severity of systemic adverse events [ Time Frame: Throughout the duration of the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • 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 ]
  • 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 ]
    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 ]
    Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
  • Levels of RN6G over time to determine pharamacokinetic parameters [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ]
  • Temporal changes in plasma levels of Aβ(1-X) (total Aβ) [ Time Frame: Day 1, 2, 7, 14, 21, 28, 42, 56, 84, 168 ]
  • Levels of antibodies against RN6G [ Time Frame: Day 0, 14, 28, 56, 84, 168 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Age-Related Maculopathy
  • Age-Related Maculopathies
  • Eye Diseases
  • Retinal Degeneration
  • Macular Degeneration
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Arm 1
Interventions:
  • Biological: RN6G
  • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
45
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877032
Other Study ID Numbers  ICMJE B1181001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

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