Geographic AtrophyPhase 2NCT01603043
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 study testing Al-78898A in people with Geographic Atrophy, run by Alcon Research.
Trial 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 more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- Al-78898A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
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.
- Conditions
- Geographic Atrophy
- Being tested
- Al-78898A, Sham injection
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration, Intravitreal injection
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al-78898ADrug
0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
Sham injectionDrug
Mock injection administered as an empty hub without needle
| Study group | Role | What they receive |
|---|---|---|
| AL-78898A | Experimental | 1 intravitreal injection per month for up to 12 months Receives: Drug: Al-78898A |
| Sham Injection | Sham comparator | 1 mock injection per month for 12 months Receives: Drug: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (injection visit), Month 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Day 0), Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mehdi Hosseini, MD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603043
- Sponsor's protocol ID
- C-12-020
- Status last verified
- Dec 2013
- First submitted
- 18 May 2012
- Last updated
- 20 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01603043
- Acronym / sponsor ID
- C-12-020
- Conditions
- Geographic Atrophy
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration, Intravitreal injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management Decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-78898A | Experimental | Drug: Al-78898A1 intravitreal injection per month for up to 12 months |
| Sham Injection | Sham comparator | Drug: Sham injection1 mock injection per month for 12 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Al-78898A0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection | Drug | AL-78898A |
| Sham injectionMock injection administered as an empty hub without needle | Drug | Sham Injection |
Primary outcome
Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging
Time frame: 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.
2 secondary outcomes
Yearly GA Lesion Size Growth Rate
Time frame: Baseline (Day 0), up to Month 12
Mean Change From Baseline in BCVA at Month 12
Time frame: Baseline (Day 0), Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Hosseini, MD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Al-78898A in people with Geographic Atrophy, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging (time frame: Day 0 (injection visit), Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.