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Trial record 1 of 2 for:    gsk geographic atrophy
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Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342926
First Posted: April 27, 2011
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atrophy, Geographic
Interventions: Drug: GSK933776
Drug: 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
This study was a parallel-group randomized study consisted of a screening visit, where 240 participants entered the observation period (minimum of 4 months), a Baseline visit at the end of observation phase, where 191 were randomized, and was followed by the treatment period (18 months), and a follow-up visit (3 months) after last dose.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The total duration of participation was approximately 25 months following screening.

Reporting Groups
  Description
Placebo Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
GSK933776 (3 mg/kg) Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
GSK933776 (6 mg/kg) Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
GSK933776 (15 mg/kg) Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.

Participant Flow:   Overall Study
    Placebo   GSK933776 (3 mg/kg)   GSK933776 (6 mg/kg)   GSK933776 (15 mg/kg)
STARTED   46   46   48   51 
COMPLETED   37   31   34   39 
NOT COMPLETED   9   15   14   12 
Adverse Event                5                8                10                7 
Lost to Follow-up                0                1                1                0 
Investigator Discretion                2                2                0                0 
Withdrawal by Subject                2                4                3                5 



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo via intravenous infusion
GSK933776 3 mg/kg 3 mg/kg administration of GSK933776 via intravenous infusion
GSK933776 6 mg/kg 6 mg/kg administration of GSK933776 via intravenous infusion
GSK933776 15 mg/kg 15 mg/kg administration of GSK933776 via intravenous infusion
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK933776 3 mg/kg   GSK933776 6 mg/kg   GSK933776 15 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   46   48   51   191 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.3  (9.55)   77.2  (9.09)   77.5  (8.57)   78.6  (7.22)   77.2  (8.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      27  58.7%      29  63.0%      26  54.2%      27  52.9%      109  57.1% 
Male      19  41.3%      17  37.0%      22  45.8%      24  47.1%      82  42.9% 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage   1   0   0   0   1 
White   45   46   48   51   190 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye   [ Time Frame: Baseline (BL), 6 months, 12 months and 18 months ]

2.  Primary:   Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period   [ Time Frame: Up to 21 months ]

3.  Primary:   Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period   [ Time Frame: Up to 21 months ]

4.  Primary:   Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to 21 months ]

5.  Primary:   Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)   [ Time Frame: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit ]

6.  Primary:   Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)   [ Time Frame: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit ]

7.  Primary:   Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)   [ Time Frame: At any point from Baseline through follow-up visit. ]

8.  Primary:   Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)   [ Time Frame: Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal ]

9.  Secondary:   Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye   [ Time Frame: Baseline, 6 months, 12 months and 18 months ]

10.  Secondary:   Change From Baseline in Area of Total hypoAF in Study Eye   [ Time Frame: Baseline, 6 months, 12 months and 18 months ]

11.  Secondary:   Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye   [ Time Frame: Month 12 and Month 18 ]

12.  Secondary:   Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18   [ Time Frame: Baseline and every month up to Month 18 ]

13.  Secondary:   Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants   [ Time Frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 ]

14.  Secondary:   Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants   [ Time Frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 ]

15.  Secondary:   Clearance (CL) of GSK933776 in Geographic Atrophy Participants   [ Time Frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 ]

16.  Secondary:   Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants   [ Time Frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 ]

17.  Secondary:   Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling   [ Time Frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 ]

18.  Secondary:   The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22)   [ Time Frame: Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18 ]


  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
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  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01342926     History of Changes
Other Study ID Numbers: 114341
First Submitted: April 26, 2011
First Posted: April 27, 2011
Results First Submitted: November 30, 2016
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017