Age Related Macular DegenerationPhase 2NCT00992563
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
A Phase 2 study testing AL-39324 ophthalmic suspension and Ranibizumab 10 mg/mL in people with Age Related Macular Degeneration, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- AL-39324 ophthalmic suspension and Ranibizumab 10 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to give written informed consent, make the required study visits and follow instructions;
- The study eye:
- must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;
- lesion must be no larger than 30 mm2;
- must have edema measuring greater than 340 μm;
- must have a visual score between 73 and 34 letters, inclusive;
- must be able to have clear picture taken of the back of the eye;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- The study eye must not have been treated for exudative AMD previously;
- The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;
- The study eye must not have uncontrolled glaucoma;
- The study eye must not be missing a lens;
- Must not be taking any medication that is toxic to the lens;
- Must not be taking oral or ocular corticosteroids;
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- Must not have an unstable or progressive condition that would interfere with study visits;
- Must not have allergies to any component of the test article or sensitivity to fluorescein dye;
- If female, must not be pregnant or nursing and must agree to adequate birth control;
- Must not be participating in another drug or device study within 30 days of screening for this study;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration
The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.
Read the detailed description
Following a single administration, patients will be followed for 6 months postinjection.
- Conditions
- Age Related Macular Degeneration
- Being tested
- AL-39324 ophthalmic suspension, Ranibizumab 10 mg/mL
- Keywords
- wet age-related macular degeneration, exudative
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-39324 ophthalmic suspensionDrug
Ranibizumab 10 mg/mLDrug
Also called Lucentis®
| Study group | Role | What they receive |
|---|---|---|
| AL-39324 Concentration Level A | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection Receives: Drug: AL-39324 ophthalmic suspension |
| AL-39324 Concentration Level B | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection Receives: Drug: AL-39324 ophthalmic suspension |
| AL-39324 Concentration Level C | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection Receives: Drug: AL-39324 ophthalmic suspension |
| AL-39324 Concentration Level D | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection Receives: Drug: AL-39324 ophthalmic suspension |
| AL-39324 Concentration Level E | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection Receives: Drug: AL-39324 ophthalmic suspension |
| Lucentis | Active comparator | Ranibizumab 10 mg/mL solution, single intravitreal injection Receives: Drug: Ranibizumab 10 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of targeted adverse events occurring in the study eye
Measured: Up to Day 7 after injection
Secondary outcomes (1)
Mean change from baseline in central foveal thickness (CFT) at Month 1
Measured: Baseline (Day 0), Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer M. Kissner, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992563
- Sponsor's protocol ID
- C-09-023
- Status last verified
- Jul 2014
- First submitted
- 7 Oct 2009
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00992563
- Acronym / sponsor ID
- C-09-023
- Conditions
- Age Related Macular Degeneration
- Keywords
- wet age-related macular degeneration, exudative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
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 is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.
Detailed description
Following a single administration, patients will be followed for 6 months postinjection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AL-39324 Concentration Level A | Experimental | Drug: AL-39324 ophthalmic suspensionAL-39324 ophthalmic suspension, single intravitreal injection |
| AL-39324 Concentration Level B | Experimental | Drug: AL-39324 ophthalmic suspensionAL-39324 ophthalmic suspension, single intravitreal injection |
| AL-39324 Concentration Level C | Experimental | Drug: AL-39324 ophthalmic suspensionAL-39324 ophthalmic suspension, single intravitreal injection |
| AL-39324 Concentration Level D | Experimental | Drug: AL-39324 ophthalmic suspensionAL-39324 ophthalmic suspension, single intravitreal injection |
| AL-39324 Concentration Level E | Experimental | Drug: AL-39324 ophthalmic suspensionAL-39324 ophthalmic suspension, single intravitreal injection |
| Lucentis | Active comparator | Drug: Ranibizumab 10 mg/mLRanibizumab 10 mg/mL solution, single intravitreal injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to give written informed consent, make the required study visits and follow instructions;
- The study eye:
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (11 listed)
- The study eye must not have been treated for exudative AMD previously;
- The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;
- The study eye must not have uncontrolled glaucoma;
- The study eye must not be missing a lens;
- Must not be taking any medication that is toxic to the lens;
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-39324 ophthalmic suspension | Drug | AL-39324 Concentration Level A, AL-39324 Concentration Level B, AL-39324 Concentration Level C, AL-39324 Concentration Level D, AL-39324 Concentration Level E |
| Ranibizumab 10 mg/mLAlso: Lucentis® | Drug | Lucentis |
Primary outcome
Incidence of targeted adverse events occurring in the study eye
Time frame: Up to Day 7 after injection
1 secondary outcome
Mean change from baseline in central foveal thickness (CFT) at Month 1
Time frame: Baseline (Day 0), Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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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.
Jennifer M. Kissner, Ph.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-39324 ophthalmic suspension and Ranibizumab 10 mg/mL in people with 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 18 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of targeted adverse events occurring in the study eye (time frame: Up to Day 7 after injection). 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 18 Jul 2014.