Dry AMDPhase 3NCT00307398
Anecortave Acetate Risk-Reduction Trial (AART)
A Phase 3 study testing Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg in people with Dry AMD, run by Alcon Research at 1 site in United States.
Trial summary
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry AMD
- What is being tested?
- Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,596 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2009
- Phase
- Phase 3
- 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
- Dry AMD study eye, Wet AMD non-study eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Age
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Study Centers in the United States and Globally
Fort Worth, Texas, 76134
About this study
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
- Conditions
- Dry AMD
- Being tested
- Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg, Anecortave Acetate Vehicle
- Keywords
- AMD, Dry AMD, Drusen, CNV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mgDrug
One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.
Anecortave Acetate VehicleOther
One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.
| Study group | Role | What they receive |
|---|---|---|
| AL-3789 | Experimental | One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months. Receives: Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg |
| Anecortave Acetate Vehicle | Sham comparator | One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye. Receives: Other: Anecortave Acetate Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48
ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.
Measured: Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMar 2004
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry AMDStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Zilliox, Study director, Study Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307398
- Sponsor's protocol ID
- C-02-60
- Status last verified
- May 2009
- First submitted
- 24 Mar 2006
- Last updated
- 28 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anecortave Acetate Risk-Reduction Trial (AART)
- ClinicalTrials.gov ID
- NCT00307398
- Acronym / sponsor ID
- C-02-60
- Conditions
- Dry AMD
- Keywords
- AMD, Dry AMD, Drusen, CNV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 2,596 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Mar 2006 (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.
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-3789 | Experimental | Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mgOne injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months. |
| Anecortave Acetate Vehicle | Sham comparator | Other: Anecortave Acetate VehicleOne sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dry AMD study eye, Wet AMD non-study eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Age
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mgOne 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals. | Drug | AL-3789 |
| Anecortave Acetate VehicleOne 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye. | Other | Anecortave Acetate Vehicle |
Primary outcome
Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48
Time frame: Month 48
ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.
Results and safety
The study was stopped early (reason given: Management decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
Patricia Zilliox study director
Study Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg in people with Dry AMD, run by Alcon Research at 1 site in United States.
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 2 inclusion and 2 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 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Management decision). Results are not available in the source record.
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?
Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 (time frame: Month 48). 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 28 Nov 2012.