Geographic Atrophy Treatment Evaluation (GATE)

June 4, 2014 updated by: Alcon Research

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

772

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
Time Frame: 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.
Baseline, up to Month 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Sally Scheib, Sr. Clinical Lead, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-08-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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