12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)
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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. |
ClinicalTrials.gov Identifier: NCT01362348 |
Recruitment Status :
Terminated
(Lack of efficacy identified during a preliminary analysis)
First Posted : May 30, 2011
Results First Posted : August 21, 2017
Last Update Posted : September 21, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Macular Degeneration |
Intervention |
Drug: pazopanib eye drops |
Enrollment | 19 |
Participant Flow
Recruitment Details | This study was conducted at 10 sites in the United States, Germany and France from 7 July 2011 was early terminated on 22 Mar 2012 and completed on 16 April 2012. The study was terminated due to lack of efficacy. |
Pre-assignment Details |
Arm/Group Title | Pazopanib 10 mg/mL QID |
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Eligible participants instilled a single drop (approximately 40 micro liters ) of the pazopanib ophthalmic solution 10 milligram per millimeter (mg/mL) via topical ocular route to the study eye at approximate 5 hour intervals four times a day (QID) during the non-sleep period for a duration of 12 weeks. |
Period Title: Overall Study | |
Started | 19 |
Completed | 5 |
Not Completed | 14 |
Reason Not Completed | |
Protocol-defined stopping criteria | 9 |
Study closed/terminated | 5 |
Baseline Characteristics
Arm/Group Title | Pazopanib 10 mg/mL QID | |
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Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks. | |
Overall Number of Baseline Participants | 19 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 19 participants | |
76.3 (6.65) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
Female |
14 73.7%
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Male |
5 26.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
19 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01362348 |
Other Study ID Numbers: |
114987 |
First Submitted: | May 19, 2011 |
First Posted: | May 30, 2011 |
Results First Submitted: | July 18, 2017 |
Results First Posted: | August 21, 2017 |
Last Update Posted: | September 21, 2017 |