Geographic AtrophyPhase 3GATENCT00890097
Geographic Atrophy Treatment Evaluation
A Phase 3 study testing AL-8309B Ophthalmic Solution in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Alcon Research.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Geographic Atrophy, Age-Related Macular Degeneration
- What is being tested?
- AL-8309B Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 772 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to May 2012
- Phase
- Phase 3
- 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
- Willing to give written informed consent, make required study visits, and follow instructions.
- Able to administer eye drops or have a caretaker to administer the eye drops.
- Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pregnant, nursing, or not using adequate contraception.
- Ocular disease in the study eye, other than non-exudative AMD.
- History of cataract surgery in either eye within the past 3 months of screening.
- History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
- Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
- Participation in an investigational drug or device study within 30 days of screening.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Being tested
- AL-8309B Ophthalmic Solution, AL-8309B Vehicle
- Keywords
- Geographic Atrophy, GA, Age-Related Macular Degeneration, AMD
- 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-8309B Ophthalmic SolutionDrug
AL-8309B VehicleDrug
Inactive ingredients used as placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| AL-8309B 1.0% | Experimental | AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months Receives: Drug: AL-8309B Ophthalmic Solution |
| AL-8309B 1.75% | Experimental | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months Receives: Drug: AL-8309B Ophthalmic Solution |
| Vehicle | Placebo comparator | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months Receives: Drug: AL-8309B Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Measured: Baseline, up to Month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Treatment ineffective
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sally Scheib, Sr. Clinical Lead, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890097
- Sponsor's protocol ID
- C-08-36
- Acronym
- GATE
- Status last verified
- Jun 2014
- First submitted
- 27 Apr 2009
- Last updated
- 3 Jul 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 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00890097
- Acronym / sponsor ID
- GATE / C-08-36
- Keywords
- Geographic Atrophy, GA, Age-Related Macular Degeneration, AMD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment ineffective
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Posted 3 Jul 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 evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-8309B 1.0% | Experimental | Drug: AL-8309B Ophthalmic SolutionAL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months |
| AL-8309B 1.75% | Experimental | Drug: AL-8309B Ophthalmic SolutionAL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| Vehicle | Placebo comparator | Drug: AL-8309B VehicleAL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to give written informed consent, make required study visits, and follow instructions.
- Able to administer eye drops or have a caretaker to administer the eye drops.
- Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Pregnant, nursing, or not using adequate contraception.
- Ocular disease in the study eye, other than non-exudative AMD.
- History of cataract surgery in either eye within the past 3 months of screening.
- History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
- Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
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-8309B Ophthalmic Solution | Drug | AL-8309B 1.0%, AL-8309B 1.75% |
| AL-8309B VehicleInactive ingredients used as placebo comparator | Drug | Vehicle |
Primary outcome
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
Time frame: Baseline, up to Month 30
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Geographic Atrophy
Active, not recruitingObservational study
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
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A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
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Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
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A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
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.
Sally Scheib, Sr. Clinical Lead study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL-8309B Ophthalmic Solution in people with Geographic Atrophy and Age-Related Macular Degeneration, 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 4 inclusion and 7 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 3 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Jul 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 Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging (time frame: Baseline, up to Month 30). 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 3 Jul 2014.