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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00890097
Other study ID # C-08-36
Secondary ID
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


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
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