A Phase 2 interventional study of Al-78898A and Sham injection in Geographic Atrophy, sponsored by Alcon Research. Terminated. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-01-20.
Sponsored by Alcon Research · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
1 intravitreal injection per month for up to 12 months
Drug: Al-78898A
1 mock injection per month for 12 months
Drug: Sham injection
0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
Mock injection administered as an empty hub without needle
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
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
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
Participants were recruited from 7 study centers located in the United States.
| Milestone | AL-78898A | Sham Injection |
|---|---|---|
| Started | 7 | 3 |
| Completed | 0 | 0 |
| Not completed | 7 | 3 |
| Withdrew: Study futility | 7 | 3 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AL-78898A | — | 0/7 (0%) | 4/7 (57.1%) |
| Sham Injection | — | 0/3 (0%) | 1/3 (33.3%) |
| Event | AL-78898A | Sham Injection |
|---|---|---|
| Product depositGeneral disorders | 4/7 | 0/3 |
| Conjunctival haemorrhageEye disorders | 2/7 | 1/3 |
| Retinal oedemaEye disorders | 0/7 | 1/3 |
| Herpes zosterInfections and infestations | 0/7 | 1/3 |
| Eye pruritusEye disorders | 1/7 | 0/3 |
| Ocular hyperaemiaEye disorders | 1/7 | 0/3 |
| Vitreous floatersEye disorders | 1/7 | 0/3 |
| Vitreous haemorrhageEye disorders | 1/7 | 0/3 |
| ExcoriationInjury, poisoning and procedural complications | 1/7 | 0/3 |
| InjuryInjury, poisoning and procedural complications | 1/7 | 0/3 |
| Age, Categorical(Participants) | AL-78898A | Sham Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 7 | 3 | 10 |
| Sex: Female, Male(Participants) | AL-78898A | Sham Injection | Total |
|---|---|---|---|
| Female | 6 | 1 | 7 |
| Male | 1 | 2 | 3 |
No study locations are listed for this record.
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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