Open-angle GlaucomaPhase 2NCT00451152
Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
A Phase 2 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL in people with Open-angle Glaucoma, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated 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, 30 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2009
- 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
- Diagnosis of open-angle glaucoma;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pseudoexfoliation;
- Pigment dispersion component;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
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 was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.
- Conditions
- Open-angle Glaucoma
- Being tested
- Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Vehicle
- Keywords
- 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, 30 mg/mLDrug
Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.
Anecortave Acetate VehicleOther
Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate Depot | Experimental | Not described Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| Anecortave Acetate Vehicle | Placebo comparator | Not described Receives: Other: Anecortave Acetate Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Measured: 3 months
Secondary outcomes (1)
Percent Treatment Failures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2009
- Study completionJul 2009
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.
- 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, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451152
- Sponsor's protocol ID
- C-06-19
- Status last verified
- May 2012
- First submitted
- 21 Mar 2007
- 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
- A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00451152
- Acronym / sponsor ID
- C-06-19
- Conditions
- Open-angle Glaucoma
- Keywords
- glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Mar 2007 (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 evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Anecortave Acetate Depot | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| Anecortave Acetate Vehicle | Placebo comparator | Other: Anecortave Acetate Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of open-angle glaucoma;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Pseudoexfoliation;
- 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, 30 mg/mLAdministered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months. | Drug | Anecortave Acetate Depot |
| Anecortave Acetate VehicleAdministered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months. | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: 3 months
1 secondary outcome
Percent Treatment Failures
Time frame: 3 months
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, Ph.D. 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 2 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL in people with Open-angle Glaucoma, 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 3 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.
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 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 Intraocular Pressure (IOP) (time frame: 3 months). 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.