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

A Multicenter, Randomized, Single-Masked, Sham-Controlled, Proof-of-Concept Study of Intravitreal AL-78898A in Patients With Bilateral Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)

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.

Study Overview

• Status: Terminated
• Conditions: Geographic Atrophy
• Intervention / Treatment: Drug: Al-78898A; Drug: Sham injection

Detailed Description

Participants meeting inclusion/exclusion criteria were randomized in a 2:1 ratio to receive AL-78898A or a sham injection. The study eye was assessed before and after each injection to ensure that the injection procedure and/or study medication had not endangered the health of the eye. The Investigator determined each month whether the patient was eligible to receive the next injection. The study was terminated due to a high likelihood that continued enrollment would reach the predefined study stopping criteria based upon the number of patients with drug deposit formation, which made an assessment of efficacy futile.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

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:

• 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.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AL-78898A; 1 intravitreal injection per month for up to 12 months	Drug: Al-78898A; 0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
SHAM_COMPARATOR: Sham Injection; 1 mock injection per month for 12 months	Drug: Sham injection; Mock injection administered as an empty hub without needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yearly GA Lesion Size Growth Rate	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.	Baseline (Day 0), up to Month 12
Mean Change From Baseline in BCVA at Month 12	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.	Baseline (Day 0), Month 12

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Mehdi Hosseini, MD, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: May 18, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (ESTIMATE): May 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Age-Related Macular Degeneration; Intravitreal injection; Geographic Atrophy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: C-12-020