Geographic Atrophy Treatment Evaluation

Age-Related Macular Degeneration Clinical Trial

— GATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00890097
• Other study ID #: C-08-36
• Status: Terminated
• Phase: Phase 3
• First received: April 27, 2009
• Last updated: June 4, 2014
• Start date: April 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 772
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• AL-8309B Ophthalmic Solution

• AL-8309B Vehicle
Inactive ingredients used as placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No