Eye DiseasesPhase 2NCT00315640
Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
A Phase 2 study testing Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Suspension Depot, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Eye Diseases, run by Alcon Research at 12 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Suspension Depot, 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
- 70 participants
- Where
- 12 sitesin 8 countries
- Study dates
- Dec 2005to 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
- Either gender
- 18 years of age or older
- IOP elevation caused by steroid usage
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Under 18 years of age
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
United States5 sites
Detroit
Detroit, Michigan, 48202
Study site
Fort Worth, Texas, 76134
Houston
Houston, Texas, 77030
Jacksonville
Jacksonville, Florida, 32204
Miami
Miami, Florida, 33136
About this study
Official title: A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.
- Conditions
- Eye Diseases
- Being tested
- Anecortave Acetate Sterile Suspension, 6 mg/mL, Anecortave Acetate Suspension Depot, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL, Anecortave Acetate Vehicle
- Keywords
- Elevated IOP due to intravitreal triamcinolone therapy
- Medical subject headings
- Eye Diseases
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
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Anecortave Acetate Suspension Depot, 30 mg/mLDrug
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Anecortave Acetate Sterile Suspension, 60 mg/mLDrug
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Anecortave Acetate VehicleOther
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate 3 mg Depot | Experimental | One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Receives: Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL |
| Anecortave Acetate 15 mg Depot | Experimental | One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Receives: Drug: Anecortave Acetate Suspension Depot, 30 mg/mL |
| Anecortave Acetate 30 mg Depot | Experimental | One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL |
| Anecortave Acetate Vehicle | Other | 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 change in IOP at Week 4 from Baseline
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startDec 2005
- 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 Eye DiseasesStudies 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
- 70 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
- NCT00315640
- Sponsor's protocol ID
- C-05-03
- Other IDs
- 2005-001598-93, 2005
- Status last verified
- Jan 2010
- First submitted
- 17 Apr 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 Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
- ClinicalTrials.gov ID
- NCT00315640
- Acronym / sponsor ID
- C-05-03
- Conditions
- Eye Diseases
- Keywords
- Elevated IOP due to intravitreal triamcinolone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Apr 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 and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.
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/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye |
| Anecortave Acetate 15 mg Depot | Experimental | Drug: Anecortave Acetate Suspension Depot, 30 mg/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye |
| Anecortave Acetate 30 mg Depot | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye |
| Anecortave Acetate Vehicle | Other | 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 (4 listed)
- Either gender
- 18 years of age or older
- IOP elevation caused by steroid usage
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (2 listed)
- Under 18 years of age
- 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/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug | Anecortave Acetate 3 mg Depot |
| Anecortave Acetate Suspension Depot, 30 mg/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug | Anecortave Acetate 15 mg Depot |
| Anecortave Acetate Sterile Suspension, 60 mg/mLOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug | Anecortave Acetate 30 mg Depot |
| Anecortave Acetate VehicleOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean change in IOP at Week 4 from Baseline
Time frame: Week 4
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
12 sites in 8 countries: 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 Suspension Depot, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Eye Diseases, run by Alcon Research at 12 sites in 8 countries.
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 4 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 12 sites in United States, Brazil, Hungary, Italy, Netherlands and 3 more countries. 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. 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 IOP at Week 4 from Baseline (time frame: Week 4). 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.