Open-Angle GlaucomaPhase 2NCT00788541
A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 3.75 mg/mL and Anecortave Acetate Sterile Suspension, 96 mg/mL in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 3.75 mg/mL and Anecortave Acetate Sterile Suspension, 96 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 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
- Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Prior angle surgery in the study eye, severe visual field loss in either eye;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A Dose-Volume 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 assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes 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, Ocular Hypertension
- Being tested
- Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 3.75 mg/mL, Anecortave Acetate Sterile Suspension, 96 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/ML, Anecortave Acetate Vehicle
- Keywords
- Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
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
Administered as an injection into an anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 3.75 mg/mLDrug
Administered as an injection into an anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 96 mg/mLDrug
Administered as an injection into an anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 60 mg/MLDrug
Administered as an injection into an anterior juxtascleral depot
Anecortave Acetate VehicleOther
Administered as an injection into an anterior juxtascleral depot
| Study group | Role | What they receive |
|---|---|---|
| 3 mg Anecortave Acetate, low volume high dose | Experimental | Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. Receives: Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL |
| 3 mg Anecortave Acetate, high volume low dose | Experimental | Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. Receives: Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL |
| 48 mg Anecortave Acetate, low volume high dose | Experimental | Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. Receives: Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL |
| 48 mg Anecortave Acetate, high volume low dose | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML |
| Anecortave Acetate Vehicle, low volume | Placebo comparator | Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. Receives: Other: Anecortave Acetate Vehicle |
| Anecortave Acetate Vehicle, high volume | Placebo comparator | Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months. 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
Measured: 6 months
Secondary outcomes (1)
Percent of patients who remain rescue-medication free
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 posted11 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Project cancellation
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 197 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
- NCT00788541
- Sponsor's protocol ID
- C-08-049
- Status last verified
- Nov 2012
- First submitted
- 7 Nov 2008
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00788541
- Acronym / sponsor ID
- C-08-049
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project cancellation
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Nov 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 assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 3 mg Anecortave Acetate, low volume high dose | Experimental | Drug: Anecortave Acetate Sterile Suspension, 6 mg/mLAnecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. |
| 3 mg Anecortave Acetate, high volume low dose | Experimental | Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mLAnecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. |
| 48 mg Anecortave Acetate, low volume high dose | Experimental | Drug: Anecortave Acetate Sterile Suspension, 96 mg/mLAnecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. |
| 48 mg Anecortave Acetate, high volume low dose | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/MLAnecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. |
| Anecortave Acetate Vehicle, low volume | Placebo comparator | Other: Anecortave Acetate VehicleAnecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. |
| Anecortave Acetate Vehicle, high volume | Placebo comparator | Other: Anecortave Acetate VehicleAnecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Prior angle surgery in the study eye, severe visual field loss in either eye;
- 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/mLAdministered as an injection into an anterior juxtascleral depot | Drug | 3 mg Anecortave Acetate, low volume high dose |
| Anecortave Acetate Sterile Suspension, 3.75 mg/mLAdministered as an injection into an anterior juxtascleral depot | Drug | 3 mg Anecortave Acetate, high volume low dose |
| Anecortave Acetate Sterile Suspension, 96 mg/mLAdministered as an injection into an anterior juxtascleral depot | Drug | 48 mg Anecortave Acetate, low volume high dose |
| Anecortave Acetate Sterile Suspension, 60 mg/MLAdministered as an injection into an anterior juxtascleral depot | Drug | 48 mg Anecortave Acetate, high volume low dose |
| Anecortave Acetate VehicleAdministered as an injection into an anterior juxtascleral depot | Other | Anecortave Acetate Vehicle, high volume, Anecortave Acetate Vehicle, low volume |
Primary outcome
Mean Intraocular Pressure
Time frame: 6 months
1 secondary outcome
Percent of patients who remain rescue-medication free
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: Project cancellation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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 study testing Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Sterile Suspension, 3.75 mg/mL and Anecortave Acetate Sterile Suspension, 96 mg/mL in people with Open-Angle Glaucoma and Ocular 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: stopped early, as of the sponsor's last update on 30 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 was stopped early (reason given: Project cancellation). 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?
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 Nov 2012.