Geographic Atrophy Treatment Evaluation (GATE)

Alcon

Status and phase: Terminated; Phase 3

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Treatments: Drug: AL-8309B Ophthalmic Solution; Drug: AL-8309B Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890097

C-08-36

Details and patient eligibility

About

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).

Enrollment: 772 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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772 participants in 3 patient groups, including a placebo group

AL-8309B 1.0%

Experimental group

Description:

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

Treatment:

Drug: AL-8309B Ophthalmic Solution

AL-8309B 1.75%

Experimental group

Description:

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

Treatment:

Drug: AL-8309B Ophthalmic Solution

Vehicle

Placebo Comparator group

Description:

AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months

Treatment:

Drug: AL-8309B Vehicle