Geographic Atrophy Treatment Evaluation

Phase 3TerminatedNCT00890097

Alcon Research772 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

772

Conditions

Geographic Atrophy Age-Related Macular Degeneration

Interventions

AL-8309B Ophthalmic SolutionDRUG

AL-8309B VehicleDRUG

Inactive ingredients used as placebo comparator

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, up to Month 30

Data from ClinicalTrials.gov

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