A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)

NCT01603043 | Terminated Phase 2 Results DMC

• 1 other identifier: C-12-020
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.

Conditions

Geographic Atrophy

Keywords

Geographic Atrophy; Age-Related Macular Degeneration; Intravitreal injection

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging

  Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.

  Day 0 (injection visit), Month 12

Secondary Outcomes (2)

• Yearly GA Lesion Size Growth Rate

  Baseline (Day 0), up to Month 12

• Mean Change From Baseline in BCVA at Month 12

  Baseline (Day 0), Month 12

Study Arms (2)

AL-78898A

EXPERIMENTAL

1 intravitreal injection per month for up to 12 months

Drug: Al-78898A

Sham Injection

SHAM COMPARATOR

1 mock injection per month for 12 months

Drug: Sham injection

Interventions

Al-78898A DRUG

0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection

AL-78898A

Sham injection DRUG

Mock injection administered as an empty hub without needle

Sham Injection

Eligibility Criteria

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

You may qualify if:

• Ability to provide informed consent and comply with the protocol.
• Diagnosis of bilateral geographic atrophy (GA) of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization.
• Study eye: Maximum best-corrected visual acuity (BCVA) of 55 letters (20/80 Snellen equivalent) and a minimum BCVA of 20 letters (20/400 Snellen equivalent) at screening
• BCVA of 20 letters (20/400 Snellen equivalent) or better in the non treated eye at screening without conditions other than AMD that, in the opinion of the investigator, could cause a rapid loss of vision.

You may not qualify if:

• Any history or current evidence of exudative ("wet") AMD in study eye.
• Retinal disease other than AMD in the study eye.
• Any ophthalmologic condition in study eye that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination, such as advanced cataract or corneal abnormalities.
• Any ophthalmologic condition in study eye that prevents adequate imaging of the retina judged by the site or reading center.
• A history or current medical diagnosis of glaucoma or ocular hypertension in study eye.
• Any ophthalmic condition in study eye that may require surgery during the study period.
• Current ocular or periocular infection in the study eye.
• History of any disease or current use of medication expected to cause systemic or ocular immunosuppression, such as RESTASIS®.
• History of uveitis or endophthalmitis in the study eye.
• History of intraocular surgery (including cataract surgery) in the study eye within 90 days prior to dosing.
• History of intravitreal or periocular injection in the study eye at anytime.
• Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or during active period of drug (whichever is longer) prior to the start of study treatment.
• History of any medical or psychiatric condition, or substance abuse, that in the Investigator's opinion is likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
• Women of child bearing potential UNLESS they are using a highly effective method of birth control.
• Known or suspected allergy or hypersensitivity to fluorescein or other injectables.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Yamini Patel, PhD, Clinical Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Mehdi Hosseini, MD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 20, 2014
• Results First Posted: January 20, 2014

Record last verified: 2013-12