Open-angle GlaucomaPhase 2NCT00320203
Anecortave Acetate in Patients With Open-angle Glaucoma
A Phase 2 study testing Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Open-angle Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Anecortave Acetate Sterile Suspension, 6 mg/mL, 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?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jan 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older with open-angle glaucoma.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
- Conditions
- Open-angle Glaucoma
- Being tested
- Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL, Anecortave Acetate Vehicle
- Keywords
- open-angle, glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave Acetate Sterile Suspension, 6 mg/mLDrug
Single injection, anterior juxtascleral depot (AJD)
Anecortave Acetate Sterile Suspension, 30 mg/mLDrug
Single injection, anterior juxtascleral depot (AJD)
Anecortave Acetate Sterile Suspension, 60 mg/mLDrug
Single injection, anterior juxtascleral depot (AJD)
Anecortave Acetate VehicleOther
Single injection, anterior juxtascleral depot (AJD)
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate 3 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) Receives: Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL |
| Anecortave Acetate 15 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| Anecortave Acetate 30 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL |
| Anecortave Acetate Vehicle | Other | Single injection, anterior juxtascleral depot (AJD) Receives: Other: Anecortave Acetate Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in intraocular pressure at 9 am from baseline
Measured: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
Secondary outcomes (1)
Time to treatment failure
Measured: At time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320203
- Sponsor's protocol ID
- C-04-62
- Status last verified
- Feb 2008
- First submitted
- 1 May 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
- A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00320203
- Acronym / sponsor ID
- C-04-62
- Conditions
- Open-angle Glaucoma
- Keywords
- open-angle, glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 May 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 is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anecortave Acetate 3 mg Depot | Experimental | Drug: Anecortave Acetate Sterile Suspension, 6 mg/mLSingle injection, anterior juxtascleral depot (AJD) |
| Anecortave Acetate 15 mg Depot | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mLSingle injection, anterior juxtascleral depot (AJD) |
| Anecortave Acetate 30 mg Depot | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mLSingle injection, anterior juxtascleral depot (AJD) |
| Anecortave Acetate Vehicle | Other | Other: Anecortave Acetate VehicleSingle injection, anterior juxtascleral depot (AJD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older with open-angle glaucoma.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
- 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, 6 mg/mLSingle injection, anterior juxtascleral depot (AJD) | Drug | Anecortave Acetate 3 mg Depot |
| Anecortave Acetate Sterile Suspension, 30 mg/mLSingle injection, anterior juxtascleral depot (AJD) | Drug | Anecortave Acetate 15 mg Depot |
| Anecortave Acetate Sterile Suspension, 60 mg/mLSingle injection, anterior juxtascleral depot (AJD) | Drug | Anecortave Acetate 30 mg Depot |
| Anecortave Acetate VehicleSingle injection, anterior juxtascleral depot (AJD) | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean change in intraocular pressure at 9 am from baseline
Time frame: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
1 secondary outcome
Time to treatment failure
Time frame: At time point
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 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.
Theresa Landry study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Open-angle Glaucoma, 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 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: finished, 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.
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?
Mean change in intraocular pressure at 9 am from baseline (time frame: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12). 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.