Back to resultsA Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
Primary Purpose
Geographic Atrophy
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Al-78898A
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic Atrophy, Age-Related Macular Degeneration, Intravitreal injection
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
AL-78898A
Sham Injection
Arm Description
1 intravitreal injection per month for up to 12 months
1 mock injection per month for 12 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01603043
Brief Title
A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Management Decision
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
Keywords
Geographic Atrophy, Age-Related Macular Degeneration, Intravitreal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-78898A
Arm Type
Experimental
Arm Description
1 intravitreal injection per month for up to 12 months
Arm Title
Sham Injection
Arm Type
Sham Comparator
Arm Description
1 mock injection per month for 12 months
Intervention Type
Drug
Intervention Name(s)
Al-78898A
Intervention Description
0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
Mock injection administered as an empty hub without needle
Primary Outcome Measure Information:
Title
Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging
Description
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.
Time Frame
Day 0 (injection visit), Month 12
Secondary Outcome Measure Information:
Title
Yearly GA Lesion Size Growth Rate
Description
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.
Time Frame
Baseline (Day 0), up to Month 12
Title
Mean Change From Baseline in BCVA at Month 12
Description
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.
Time Frame
Baseline (Day 0), Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Hosseini, MD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
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