Geographic Atrophy Treatment Evaluation

Study Overview
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Brief Summary
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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).

Official Title
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The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Conditions
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Geographic Atrophy, Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: AL-8309B Ophthalmic Solution
* Drug: AL-8309B Vehicle


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-8309B 1.0%<br>AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months | Drug: AL-8309B Ophthalmic Solution<br> <br> |
| Experimental: AL-8309B 1.75%<br>AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months | Drug: AL-8309B Ophthalmic Solution<br> <br> |
| Placebo Comparator: Vehicle<br>AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months | Drug: AL-8309B Vehicle<br>* Inactive ingredients used as placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geographic Atrophy, GA, Age-Related Macular Degeneration, AMD