Open-angle GlaucomaPhase 2/3NCT00691717
Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 2/3 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL and Anecortave Acetate Sterile Suspension, 75 mg/mL in people with Open-angle Glaucoma and Oular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Oular Hypertension
- What is being tested?
- Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL and Anecortave Acetate Sterile Suspension, 75 mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2009
- 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 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patients with any form of glaucoma other than open-angle.
- 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 or Ocular Hypertension
The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Oular Hypertension
- Being tested
- Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL, Anecortave Acetate Sterile Suspension, 75 mg/mL, Anecortave Acetate Vehicle
- Keywords
- Anecortave acetate, Open-angle glaucoma, IOP, OHT
- 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 Acetate Sterile Suspension, 30 mg/mLDrug
Single administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 60 mg/mLDrug
Single administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 75 mg/mLDrug
Single administration by anterior juxtascleral depot
Anecortave Acetate VehicleOther
Single administration by anterior juxtascleral depot
| Study group | Role | What they receive |
|---|---|---|
| 24 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| 48 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL |
| 60 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye Receives: Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL |
| Anecortave Acetate Vehicle | Placebo comparator | Single depot administration of 0.8 mL in the study eye 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 at 8 am
Measured: Up to 6 months
Secondary outcomes (1)
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
Measured: Month 3, 8 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 201 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
- NCT00691717
- Sponsor's protocol ID
- C-07-36
- Status last verified
- Nov 2012
- First submitted
- 3 Jun 2008
- 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 or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00691717
- Acronym / sponsor ID
- C-07-36
- Conditions
- Open-angle Glaucoma, Oular Hypertension
- Keywords
- Anecortave acetate, Open-angle glaucoma, IOP, OHT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 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 was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 24 mg Anecortave Acetate | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mLAnecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye |
| 48 mg Anecortave Acetate | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mLAnecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye |
| 60 mg Anecortave Acetate | Experimental | Drug: Anecortave Acetate Sterile Suspension, 75 mg/mLAnecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye |
| Anecortave Acetate Vehicle | Placebo comparator | Other: Anecortave Acetate VehicleSingle depot administration of 0.8 mL in the study eye |
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 (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Patients with any form of glaucoma other than open-angle.
- 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/mLSingle administration by anterior juxtascleral depot | Drug | 24 mg Anecortave Acetate |
| Anecortave Acetate Sterile Suspension, 60 mg/mLSingle administration by anterior juxtascleral depot | Drug | 48 mg Anecortave Acetate |
| Anecortave Acetate Sterile Suspension, 75 mg/mLSingle administration by anterior juxtascleral depot | Drug | 60 mg Anecortave Acetate |
| Anecortave Acetate VehicleSingle administration by anterior juxtascleral depot | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean Intraocular Pressure at 8 am
Time frame: Up to 6 months
1 secondary outcome
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
Time frame: Month 3, 8 am
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL and Anecortave Acetate Sterile Suspension, 75 mg/mL in people with Open-angle Glaucoma and Oular Hypertension, 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: 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 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 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 at 8 am (time frame: Up to 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 28 Nov 2012.