Geographic Atrophy Treatment Evaluation

Phase 3

Terminated

• Conditions: Age-Related Macular Degeneration; Geographic Atrophy
• Interventions: Drug: AL-8309B Ophthalmic Solution; Drug: AL-8309B Vehicle

• Registration Number: NCT00890097
• Lead Sponsor: Alcon Research

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Disposition First Submitted: 2013-05-09
• Disposition First Submitted QC: 2013-05-09
• Disposition First Posted: 2013-05-16
• Status Verified: 2014-06
• Results First Submitted: 2014-06-04
• Results First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

• Willing to give written informed consent, make required study visits, and follow instructions.
• Able to administer eye drops or have a caretaker to administer the eye drops.
• Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Pregnant, nursing, or not using adequate contraception.
• Ocular disease in the study eye, other than non-exudative AMD.
• History of cataract surgery in either eye within the past 3 months of screening.
• History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
• Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
• Participation in an investigational drug or device study within 30 days of screening.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-8309B 1.0%	AL-8309B Ophthalmic Solution	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%	AL-8309B Ophthalmic Solution	AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
Vehicle	AL-8309B Vehicle	AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months

Primary Outcome Measures

Name	Time	Method
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging	Baseline, up to Month 30	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.