NCT00890097|TerminatedPhase 3ResultsDMC
Study Stopped
Treatment ineffective
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Treatment ineffective
GATE
The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Sponsor study identifier
interventional
772
0 countries
N/A
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2009
Actual (reported)April 29, 2009
Actual (reported)May 2012
Actual (reported)May 2012
Actual (reported)July 3, 2014
Actual (reported)Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Baseline, up to Month 30
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
Inactive ingredients used as placebo comparator
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sally Scheib, Sr. Clinical Lead
Alcon Research
772 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
July 3, 2014
Results First Posted
July 3, 2014
Record last verified: 2014-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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