Open-Angle GlaucomaPhase 2/3NCT00705770
A Multi-Dose Study With a Treatment for Open-Angle Glaucoma
A Phase 2/3 study testing Anecortave Acetate in people with Open-Angle Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 2008
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication
Who cannot join
- Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma
About this study
The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.
- Conditions
- Open-Angle Glaucoma
- Being tested
- Anecortave Acetate, Placebo
- Keywords
- Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave AcetateDrug
Low dose
Sustained release depot suspension
Anecortave AcetateDrug
Middle dose
Sustained release depot suspension
Anecortave AcetateDrug
High dose
Sustained release depot suspension
PlaceboDrug
Placebo treatment with vehicle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo treatment with vehicle Receives: Drug: Placebo |
| 2 | Experimental | Low dose of study medication Receives: Drug: Anecortave Acetate |
| 3 | Experimental | Middle dose of study medication Receives: Drug: Anecortave Acetate |
| 4 | Experimental | High dose of study medication Receives: Drug: Anecortave Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure
Measured: 6 months
Secondary outcomes (1)
Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Change in study design
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705770
- Sponsor's protocol ID
- C-07-58
- Status last verified
- Jul 2008
- First submitted
- 24 Jun 2008
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Dose Study With a Treatment for Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00705770
- Acronym / sponsor ID
- C-07-58
- Conditions
- Open-Angle Glaucoma
- Keywords
- Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Jun 2008 (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 determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo treatment with vehicle |
| 2 | Experimental | Drug: Anecortave AcetateLow dose of study medication |
| 3 | Experimental | Drug: Anecortave AcetateMiddle dose of study medication |
| 4 | Experimental | Drug: Anecortave AcetateHigh dose of study medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication
Key exclusion criteria (1 listed)
- Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma
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 AcetateLow dose Sustained release depot suspension | Drug | 2 |
| Anecortave AcetateMiddle dose Sustained release depot suspension | Drug | 3 |
| Anecortave AcetateHigh dose Sustained release depot suspension | Drug | 4 |
| PlaceboPlacebo treatment with vehicle | Drug | 1 |
Primary outcome
Mean Intraocular Pressure
Time frame: 6 months
1 secondary outcome
Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anecortave Acetate 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 1 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: withdrawn, as of the sponsor's last update on 30 May 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. 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 combined 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.
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 withdrawn before enrolling participants, so there are no results.
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 (time frame: 6 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 30 May 2012.