AMDPhase 3NCT00333216
Anecortave Acetate Risk-Reduction Trial (AART)
A Phase 3 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/ML in people with AMD, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD
- What is being tested?
- Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2008
- 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 in study eye, Wet AMD in non-study eye;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 50;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)
The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.
- Conditions
- AMD
- Being tested
- Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/ML, Anecortave Acetate Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave Acetate Sterile Suspension, 30 mg/mLDrug
Posterior juxtascleral administration of suspension
Anecortave Acetate Sterile Suspension, 60 mg/MLDrug
Posterior juxtascleral administration of suspension
Anecortave Acetate VehicleOther
Sham posterior juxtascleral administration of suspension
| Study group | Role | What they receive |
|---|---|---|
| 15 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| 30 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML |
| Anecortave Acetate Vehicle | Sham comparator | Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months 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 CNV in study eye
Measured: Month 48
Secondary outcomes (2)
Time to development of sight-threatening CNV
Measured: Up to 48 months
Proportion of patients with stable vision
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2005
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry Wiernas, PhD, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333216
- Sponsor's protocol ID
- C-04-30
- Status last verified
- Dec 2011
- First submitted
- 31 May 2006
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- 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
- Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00333216
- Acronym / sponsor ID
- C-04-30
- Conditions
- AMD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Jun 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.
The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 mg Anecortave Acetate | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mLAnecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months |
| 30 mg Anecortave Acetate | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/MLAnecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months |
| Anecortave Acetate Vehicle | Sham comparator | Other: Anecortave Acetate VehicleAnecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months |
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 in study eye, Wet AMD in non-study eye;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 50;
- 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 Sterile Suspension, 30 mg/mLPosterior juxtascleral administration of suspension | Drug | 15 mg Anecortave Acetate |
| Anecortave Acetate Sterile Suspension, 60 mg/MLPosterior juxtascleral administration of suspension | Drug | 30 mg Anecortave Acetate |
| Anecortave Acetate VehicleSham posterior juxtascleral administration of suspension | Other | Anecortave Acetate Vehicle |
Primary outcome
Proportion of patients with sight-threatening CNV in study eye
Time frame: Month 48
2 secondary outcomes
Time to development of sight-threatening CNV
Time frame: Up to 48 months
Proportion of patients with stable vision
Time frame: Up to 48 months
Results and safety
The study was stopped early (reason given: Lack of efficacy). 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.
Terry Wiernas, PhD study director
Study Director
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 Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/ML in people with 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: Lack of efficacy). 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 CNV in study eye (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.