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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
Results First Received: March 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Age-Related Maculopathy
Age-Related Maculopathies
Eye Diseases
Retinal Degeneration
Macular Degeneration
Interventions: Biological: RN6G
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
From a given cohort, no more than 3 participants received treatment on Day 1, the remaining participants in the respective cohort received treatment at least 24 hours thereafter. All the remaining participants were treated on same day, if required, as per site scheduling.

Reporting Groups
  Description
RN6G 0.3 mg/kg Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
RN6G 1 mg/kg Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 3 mg/kg Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 10 mg/kg Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 20 mg/kg Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 40 mg/kg Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Placebo Single intravenous infusion dose of placebo matched to RN6G on Day 1.

Participant Flow:   Overall Study
    RN6G 0.3 mg/kg   RN6G 1 mg/kg   RN6G 3 mg/kg   RN6G 10 mg/kg   RN6G 20 mg/kg   RN6G 40 mg/kg   Placebo
STARTED   6   6   6   7   6   6   20 
Treated   6   6   6   6   6   6   18 
COMPLETED   6   6   6   6   6   6   18 
NOT COMPLETED   0   0   0   1   0   0   2 
Did not meet entrance criteria                0                0                0                1                0                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.

Reporting Groups
  Description
RN6G 0.3 mg/kg Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
RN6G 1 mg/kg Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 3 mg/kg Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 10 mg/kg Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 20 mg/kg Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
RN6G 40 mg/kg Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Placebo Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Total Total of all reporting groups

Baseline Measures
   RN6G 0.3 mg/kg   RN6G 1 mg/kg   RN6G 3 mg/kg   RN6G 10 mg/kg   RN6G 20 mg/kg   RN6G 40 mg/kg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   6   6   6   6   18   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.2  (11.1)   70.2  (9.9)   65.5  (10.4)   69.2  (3.7)   67.8  (7.5)   65.0  (6.5)   67.4  (8.2)   67.6  (8.1) 
Gender 
[Units: Participants]
               
Female   4   2   5   2   5   4   14   36 
Male   2   4   1   4   1   2   4   18 


  Outcome Measures
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1.  Primary:   Incidence and Severity of Ocular Adverse Events (AEs)   [ Time Frame: Baseline up to Day 168 ]

2.  Primary:   Incidence and Severity of Systemic Adverse Events (AEs)   [ Time Frame: Baseline up to Day 168 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   Number of Participants With Anti-Drug Anti-body   [ Time Frame: Baseline up to Day 168 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00877032     History of Changes
Other Study ID Numbers: B1181001
Study First Received: April 6, 2009
Results First Received: March 20, 2015
Last Updated: March 20, 2015
Health Authority: United States: Food and Drug Administration