Geographic Atrophy Treatment Evaluation

NCT00890097 | Terminated Phase 3 Results DMC

• 1 other identifier: C-08-36
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Geographic Atrophy; Age-Related Macular Degeneration

Keywords

Geographic Atrophy; GA; Age-Related Macular Degeneration; AMD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

AL-8309B 1.0%

EXPERIMENTAL

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

AL-8309B 1.75%

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Drug: AL-8309B Vehicle

Interventions

AL-8309B Ophthalmic Solution DRUG

AL-8309B 1.0%; AL-8309B 1.75%

AL-8309B Vehicle DRUG

Inactive ingredients used as placebo comparator

Vehicle

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Dana Sager, Clinical Manager Group Leader
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sally Scheib, Sr. Clinical Lead

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06