IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
Recruitment status was Active, not recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 20, 2007 | ||||
| Last Updated Date | September 21, 2007 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Intraocular pressure [ Time Frame: Procedure ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00533962 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Visual Acuity; side effects (biomicroscopy exam) [ Time Frame: Post treatment ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients | ||||
| Official Title ICMJE | Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients | ||||
| Brief Summary | Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Anterior Juxtascleral Depot of Anecortave Acetate | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00533962 | ||||
| Other Study ID Numbers ICMJE | C-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Alcon Research | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | September 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||