Macular DegenerationPhase 3NCT00065728
Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
A Phase 3 study testing Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL in people with Macular Degeneration, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Oct 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
- Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
Central Contact Fort Worth, Texas, 76134
About this study
Official title: An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)
The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
- Conditions
- Macular Degeneration
- Being tested
- Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
- Keywords
- AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration, CNV, Anecortave Acetate
- Medical subject headings
- Macular Degeneration
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, 30 mg/mLDrug
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate, 15 mg | Experimental | One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months Receives: Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who maintained stable vision
Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)
Measured: Month 24
Mean change in best-corrected visual acuity at Month 24 from baseline
Measured: Baseline, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionOct 2008
- Study completionOct 2008
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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry Wiernas, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065728
- Sponsor's protocol ID
- C-03-15
- Status last verified
- May 2009
- First submitted
- 31 Jul 2003
- Last updated
- 16 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00065728
- Acronym / sponsor ID
- C-03-15
- Conditions
- Macular Degeneration
- Keywords
- AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration, CNV, Anecortave Acetate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Aug 2003 (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 investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anecortave Acetate, 15 mg | Experimental | Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mLOne 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 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)
- Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (1 listed)
- 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, 30 mg/mLOne 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months | Drug | Anecortave Acetate, 15 mg |
Primary outcome
Percent of patients who maintained stable vision
Time frame: Month 24
Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)
Mean change in best-corrected visual acuity at Month 24 from baseline
Time frame: Baseline, Month 24
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 16 Sep 2013.
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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
Alcon Research
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, 30 mg/mL in people with Macular Degeneration, 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 1 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 16 Sep 2013. 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. 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?
Percent of patients who maintained stable vision (time frame: Month 24). The study lists 2 primary outcomes in all. 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 16 Sep 2013.