CClinicalTrials.gg
TerminatedNCT01603043Updated Jan 20, 2014Results posted

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

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

Why this study was terminated
Management Decision
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Geographic Atrophy

Keywords

  • Geographic Atrophy
  • Age-Related Macular Degeneration
  • Intravitreal injection
03

In context

Macular Degeneration

1,473 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 10 is below the median of 51 across 984 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    AL-78898A

    1 intravitreal injection per month for up to 12 months

    Drug: Al-78898A

  • Sham comparator
    Sham Injection

    1 mock injection per month for 12 months

    Drug: Sham injection

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

06

What researchers measure

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.

    Time frame: Day 0 (injection visit), Month 12

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Jan 20, 2014

Participant flow

Participants were recruited from 7 study centers located in the United States.

Participant flow — Overall Study
MilestoneAL-78898ASham Injection
Started73
Completed00
Not completed73
Withdrew: Study futility73

Outcome measures

PrimaryMean 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

No measurements were reported for this outcome.

SecondaryYearly 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

No measurements were reported for this outcome.

SecondaryMean 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

No measurements were reported for this outcome.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
AL-78898A—0/7 (0%)4/7 (57.1%)
Sham Injection—0/3 (0%)1/3 (33.3%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventAL-78898ASham Injection
Product depositGeneral disorders4/70/3
Conjunctival haemorrhageEye disorders2/71/3
Retinal oedemaEye disorders0/71/3
Herpes zosterInfections and infestations0/71/3
Eye pruritusEye disorders1/70/3
Ocular hyperaemiaEye disorders1/70/3
Vitreous floatersEye disorders1/70/3
Vitreous haemorrhageEye disorders1/70/3
ExcoriationInjury, poisoning and procedural complications1/70/3
InjuryInjury, poisoning and procedural complications1/70/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AL-78898ASham InjectionTotal
<=18 years000
Between 18 and 65 years000
>=65 years7310
Sex: Female, Male
Sex: Female, Male(Participants)AL-78898ASham InjectionTotal
Female617
Male123
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01603043
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
May 22, 2012
Start date
Jun 2012
Primary completion
Nov 2012
Completion
Nov 2012
Results posted
Jan 20, 2014
Last update
Jan 20, 2014

Study contacts

Mehdi Hosseini, MD
study director · Alcon Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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