Uveitis, PosteriorPhase 1NCT00570479
Prophylactic Anecortave Acetate in Patients With a Retisert Implant
A Phase 1 study testing anecortave acetate in people with Uveitis, Posterior and Glaucoma, run by Texas Retina Associates at 1 site in United States.
Trial summary
Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Uveitis, Posterior, Glaucoma
- What is being tested?
- anecortave acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2010
- Phase
- Phase 1
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Approximately 24 patients with recent implantation of the Retisert implant who meet the inclusion/exclusion criteria defined below will be enrolled in the study. They will be identified from the current and future patients of the clinical practices.
- Patients must be willing to sign an informed consent form, able to make the required study visits, and able to follow instructions.
- Patient must be at least 12 years of age.
- Implantation of a Retisert implant in the last 12 weeks.
Who cannot join
- Patient has history of any medical condition which would preclude scheduled study visits or completion of the study (i.e., unstable cardiovascular disease)
- Patient has insertion of a scleral buckle in the study eye.
- Patient has known medical history of allergy or sensitivity to the steroid family of drugs.
- Patient is on anticoagulant therapy, with the exception of aspirin and antiplatelet therapy. Patient has a medical history of a bleeding disorder.
- Patient has clinical evidence of scleral thinning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Steroid-induced Glaucoma Using Anecortave Acetate
Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.
Read the detailed description
Test Article: Anecortave Acetate: 6% and 10% Sterile Suspension
Drug Study Dosage: Patients will receive an injection (0.5 mL, 0.4 mL, or 0.2 mL of the 6% Anecortave Acetate suspension or 0.5 mL of the 10% suspension) of study medication every 4 months.
Active Ingredients: Anecortave Acetate (AL-3789)
Route of Administration: Sub-Tenon injection
Objective(s): To evaluate the safety and efficacy of four dosages (50 mg, 30 mg, 24 mg, or 12 mg) of Anecortave Acetate (AA) for the prevention of steroid-induced intraocular pressure (IOP) elevations caused by Retisert.
Study Population: Approximately 24 patients
Structure: Parallel Group Duration of Treatment: 3 years
Description: Observer-masked study of the safety and efficacy of Anecortave Acetate 6% or 10 % administered by a sub-Tenon injection. Up to 24 patients with recent implantation of a Retisert implant will be given a sub-Tenon injection of either 0.5 mL, 0.4 mL, or 0.2 mL of 6% Anecortave Acetate Sterile suspension or 0.5 mL of the 10% suspension. Patients will receive periodic evaluations and re-treatment every 4 months for as long as 3 years. The end point will be an IOP which requires surgical intervention. An initial assessment of efficacy will be made at 18 months. If any patient treated with a lower dose develops an IOP of greater than 30mHg, then they are eligible to receive the 50 mg dose.
Multicenter: Yes Number of Centers: 1 Masking: Observer masked (IOP-reader)
Method of Patient Assignment:
Randomization: Yes
- Conditions
- Uveitis, Posterior, Glaucoma
- Being tested
- anecortave acetate
- Keywords
- Retisert, Uveitis, glaucoma
- Medical subject headings
- Uveitis, Posterior, Glaucoma, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anecortave acetateDrug
Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 50 mgs of anecortave acetate (0.5 ml of a 10% suspension) Receives: Drug: anecortave acetate |
| 2 | Active comparator | Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension) Receives: Drug: anecortave acetate |
| 3 | Active comparator | Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension) Receives: Drug: anecortave acetate |
| 4 | Active comparator | Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension) Receives: Drug: anecortave acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients requiring glaucoma filtering surgery
Measured: 3 years
Secondary outcomes (1)
Percentage of patients requiring topical glaucoma medication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- David G Callanan, MD, Principal investigator, Texas Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570479
- Sponsor's protocol ID
- Texas Retina DC-02
- Status last verified
- Jun 2012
- First submitted
- 9 Dec 2007
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Steroid-induced Glaucoma Using Anecortave Acetate
- ClinicalTrials.gov ID
- NCT00570479
- Acronym / sponsor ID
- Texas Retina DC-02
- Conditions
- Uveitis, Posterior, Glaucoma
- Keywords
- Retisert, Uveitis, glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Texas Retina AssociatesUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Sep 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Dec 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.
Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.
Detailed description
Test Article: Anecortave Acetate: 6% and 10% Sterile Suspension
Drug Study Dosage: Patients will receive an injection (0.5 mL, 0.4 mL, or 0.2 mL of the 6% Anecortave Acetate suspension or 0.5 mL of the 10% suspension) of study medication every 4 months.
Active Ingredients: Anecortave Acetate (AL-3789)
Route of Administration: Sub-Tenon injection
Objective(s): To evaluate the safety and efficacy of four dosages (50 mg, 30 mg, 24 mg, or 12 mg) of Anecortave Acetate (AA) for the prevention of steroid-induced intraocular pressure (IOP) elevations caused by Retisert.
Study Population: Approximately 24 patients
Structure: Parallel Group Duration of Treatment: 3 years
Description: Observer-masked study of the safety and efficacy of Anecortave Acetate 6% or 10 % administered by a sub-Tenon injection. Up to 24 patients with recent implantation of a Retisert implant will be given a sub-Tenon injection of either 0.5 mL, 0.4 mL, or 0.2 mL of 6% Anecortave Acetate Sterile suspension or 0.5 mL of the 10% suspension. Patients will receive periodic evaluations and re-treatment every 4 months for as long as 3 years. The end point will be an IOP which requires surgical intervention. An initial assessment of efficacy will be made at 18 months. If any patient treated with a lower dose develops an IOP of greater than 30mHg, then they are eligible to receive the 50 mg dose.
Multicenter: Yes Number of Centers: 1 Masking: Observer masked (IOP-reader)
Method of Patient Assignment:
Randomization: Yes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: anecortave acetate50 mgs of anecortave acetate (0.5 ml of a 10% suspension) |
| 2 | Active comparator | Drug: anecortave acetatePatients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension) |
| 3 | Active comparator | Drug: anecortave acetatePatients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension) |
| 4 | Active comparator | Drug: anecortave acetatePatients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension) |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Approximately 24 patients with recent implantation of the Retisert implant who meet the inclusion/exclusion criteria defined below will be enrolled in the study. They will be identified from the current and future patients of the clinical practices.
- Patients must be willing to sign an informed consent form, able to make the required study visits, and able to follow instructions.
- Patient must be at least 12 years of age.
- Implantation of a Retisert implant in the last 12 weeks.
Key exclusion criteria (5 listed)
- Patient has history of any medical condition which would preclude scheduled study visits or completion of the study (i.e., unstable cardiovascular disease)
- Patient has insertion of a scleral buckle in the study eye.
- Patient has known medical history of allergy or sensitivity to the steroid family of drugs.
- Patient is on anticoagulant therapy, with the exception of aspirin and antiplatelet therapy. Patient has a medical history of a bleeding disorder.
- Patient has clinical evidence of scleral thinning.
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 acetatePatients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection | Drug | 1, 2, 3, 4 |
Primary outcome
Percentage of patients requiring glaucoma filtering surgery
Time frame: 3 years
1 secondary outcome
Percentage of patients requiring topical glaucoma medication
Time frame: 3 years
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 5 Jun 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.
David G Callanan, MD principal investigator
Texas Retina Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anecortave acetate in people with Uveitis, Posterior and Glaucoma, run by Texas Retina Associates 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 4 inclusion and 5 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 5 Jun 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of patients requiring glaucoma filtering surgery (time frame: 3 years). 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 5 Jun 2012.