Geographic Atrophy
Conditions
Keywords
Geographic Atrophy, Age-Related Macular Degeneration, Intravitreal injection
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.
Interventions
DRUGAl-78898A
0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
DRUGSham injection
Mock injection administered as an empty hub without needle
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging | Day 0 (injection visit), 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yearly GA Lesion Size Growth Rate | Baseline (Day 0), up to 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. |
| Mean Change From Baseline in BCVA at Month 12 | Baseline (Day 0), 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. |
Participant flow
Recruitment details
Participants were recruited from 7 study centers located in the United States.
Participants by arm
| Arm | Count |
|---|---|
| AL-78898A 1 intravitreal injection per month for up to 12 months | 7 |
| Sham Injection 1 mock injection per month for 12 months | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Futility | 7 | 3 |
Baseline characteristics
| Characteristic | AL-78898A | Sham Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 7 | 1 / 3 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Day 0 (injection visit), Month 12
Secondary
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.
Time frame: Baseline (Day 0), Month 12
Secondary
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.
Time frame: Baseline (Day 0), up to Month 12