A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsoriSTAR Medical
About this trial
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females, 20 years of age or older
Diagnosis of open angle glaucoma (OAG) in the study eye
Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
Disqualifiers
Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3.
Any eye surgery that was performed < 90 days before Screening/Baseline visit in the study eye
Diagnosis of diabetes mellitus with HbA1C >7%
Known or suspected allergy or hypersensitivity to medical silicone
Trial design
Design model
Parallel
Treatments tested in this trial
MIGS
DeviceImplant MINIject S+ in supraciliary space
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Investigational device FG300XActive comparator 1 intervention
Group B: Investigational device FG300YActive comparator 1 intervention
Group C: Investigational device FG300ZActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader
Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader.
Time frame
1 week2
Ease of use evaluation
Ease of Use, as measured by sponsor review of the surgical procedure and surgeon feedback.
Time frame
during the surgery procedureSecondary outcomes
1
Change in Best Corrected Visual Acuity from baseline to 6-, 12- and 24-months follow-up
Best corrected visual acuity measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Change from baseline to 6-, 12- and 24-months follow-up will be evaluated.
Time frame
Baseline, 6, 12, and 24 months2
Rate of secondary surgical interventions at Month 6, Month 12 and Month 24
Cumulative rate of secondary surgical interventions due to the glaucoma device or related to glaucoma surgical procedure at Month 6, Month 12 and Month 24.
Time frame
6, 12, and 24 months3
Change in Endothelial Cell Density from baseline to 6-, 12- and 24-months follow-up
Change from baseline in endothelial cell density (ECD), measured at Month 6, Month 12, and Month 24.
Time frame
Baseline, 6, 12 and 24 months4
Cumulative Rate of Adverse Events at 6, 12 and 24 months.
Cumulative rate of adverse events (AEs), adverse device effects (ADEs), and adverse events of special interest (AESIs) at 6-, 12- and 24-months follow-up.
Time frame
6, 12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov