CTRI/2019/06/019564
Completed
未知
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL ANALYSING THE EFFECTIVENESS AND SAFETY OF MINIJECT (MINI SO627) IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS USING A SINGLE OPERATOR DELIVERY TOOL - ISM08
iSTAR Medical SA0 sites4 target enrollmentTBD
ConditionsHealth Condition 1: H40-H42- Glaucoma
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H40-H42- Glaucoma
- Sponsor
- iSTAR Medical SA
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females, 18 years of age or older.
- •2\. Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •3\. Grade 3 (open, 20\-35 degrees) or grade 4 (wide open, 35\-45 degrees) according to Shaffer Angle Grading System.
- •4\. Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.
- •5\. Patients must be willing and able to return for scheduled study\-related examinations.
- •6\. Patients must provide written informed consent.
Exclusion Criteria
- •1\. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
- •2\. Neovascular glaucoma in the study eye.
- •3\. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
- •4\. Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed ââ?°Â¥ 90 days before baseline visit in the study eye.
- •5\. Visual field defect in the 10\-degree central field in the study eye.
- •6\. Any eye surgery that was performed ââ?°Â¥ 90 days before baseline visit in the study eye.
- •7\. Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
- •8\. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •9\. Pre\-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.
- •10\. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Study for Reduction of Eye PressureHealth Condition 1: H401- Open-angle glaucomaCTRI/2021/02/030922iSTAR Medical SA
Completed
Not Applicable
Study for reduction of Eye PressureHealth Condition 1: null- PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONSCTRI/2018/03/012458iSTAR Medical SA10
Completed
Not Applicable
Study for reduction of Eye PressureCTRI/2018/02/012240iSTAR Medical SA15
Active, not recruiting
Phase 1
CLINICAL TRIAL IN THE EXPLORATION PHASE FOR TO EVALUATE SAFETY AND TOLERABILITY, OF SUBCUTANEOUS IMMUNOTHERAPY COMPARED TO PLACEBO IN PATIENTS WITH ALLERGY RHINOCONJUNCTIVITIS SENSITISED TO PARIETARIA JUDAICA, WITH AGES COMPRISED BETWEEN 18 AND 60 YEARS.PATIENTS WITH RHINOCONJUNCTIVITIS SENSITISED TO PARIETARIA JUDAICATherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2014-001459-22-ESBial Industrial Farmacéutica S.A.52
Active, not recruiting
Phase 1
An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF studyEUCTR2006-004784-58-GBniversity of Leuven Hospitals25