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

Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01577381
First received: April 11, 2012
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: December 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Age-Related Maculopathy
Interventions: Biological: RN6G
Biological: Placebo

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
PF-04382923 2.5 mg/kg PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 7.5 mg/kg PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 15.0 mg/kg PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.

Participant Flow:   Overall Study
    PF-04382923 2.5 mg/kg     PF-04382923 7.5 mg/kg     PF-04382923 15.0 mg/kg     Placebo  
STARTED     2     3     3     2  
COMPLETED     0     0     0     0  
NOT COMPLETED     2     3     3     2  
Discontinued                 2                 1                 2                 2  
Ongoing at Date of Cut-Off                 0                 2                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
PF-04382923 2.5 mg/kg PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 7.5 mg/kg PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 15.0 mg/kg PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Total Total of all reporting groups

Baseline Measures
    PF-04382923 2.5 mg/kg     PF-04382923 7.5 mg/kg     PF-04382923 15.0 mg/kg     Placebo     Total  
Number of Participants  
[units: participants]
  2     3     3     2     10  
Age  
[units: years]
Mean (Standard Deviation)
  82.5  (0.7)     71.0  (6.2)     74.0  (12.2)     73.0  (11.3)     74.6  (8.6)  
Gender  
[units: participants]
         
Female     1     3     3     0     7  
Male     1     0     0     2     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309   [ Time Frame: Baseline and Day 309 ]

2.  Primary:   Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)   [ Time Frame: Baseline and Day 449 ]

3.  Secondary:   Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

4.  Secondary:   Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

5.  Secondary:   Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

6.  Secondary:   Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

7.  Secondary:   Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

8.  Secondary:   Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

9.  Secondary:   Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

10.  Secondary:   Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

11.  Secondary:   Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

12.  Secondary:   Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

13.  Secondary:   Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

14.  Secondary:   Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

15.  Secondary:   Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

16.  Secondary:   Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

17.  Secondary:   Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

18.  Secondary:   Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study   [ Time Frame: Baseline, Month 9, Month 12, Month 15, and End of Study ]

19.  Secondary:   Number of Participants With Treatment-Emergent Laboratory Abnormalities   [ Time Frame: Day 85 and Day 169 ]

20.  Secondary:   Number of Participants With Abnormal Change From Baseline in Vital Signs   [ Time Frame: Screening, Days 28, 57, 85, 113, 141, and 169 ]

21.  Secondary:   Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings   [ Time Frame: Days 28, 57, 85, 113 and 169 ]

22.  Secondary:   Number of Participants With Positive Anti-Drug Antibody (ADA)   [ Time Frame: Day 57 and Day 169 ]

23.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness   [ Time Frame: Days 28, 57, 85, 113, 141 and 169 ]

24.  Secondary:   Number of Participants With Treatment-Related TEAEs   [ Time Frame: Days 28, 57, 85, 113, 141 and 169 ]

25.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 ]

26.  Secondary:   Minimum Observed Plasma Trough Concentration (Cmin)   [ Time Frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 ]

27.  Secondary:   Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)   [ Time Frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 ]

28.  Secondary:   Clearance at Steady State (CLss)   [ Time Frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 ]

29.  Secondary:   Accumulation Ratio (Rac) for AUCt   [ Time Frame: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 ]

30.  Secondary:   Plasma Population PK Parameters   [ Time Frame: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449 ]

31.  Secondary:   Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)   [ Time Frame: Baseline, Day 449 ]

32.  Secondary:   Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)   [ Time Frame: Baseline, Day 449 ]

33.  Secondary:   Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)   [ Time Frame: Baseline, Day 449 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The study was terminated early due to an organizational decision, which was not based on safety or efficacy concerns. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses.


  More Information
  Hide More Information

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: NCT01577381     History of Changes
Other Study ID Numbers: B1181003
2012-000823-42 ( EudraCT Number )
Study First Received: April 11, 2012
Results First Received: December 9, 2015
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration