Open Angle Glaucoma
Conditions
Brief summary
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
Interventions
DEVICEMINIject implant
MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.
Sponsors
iSTAR Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. * Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. * Glaucoma not adequately controlled
Exclusion criteria
* Diagnosis of glaucoma other than open angle glaucoma * Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System. * Neovascular glaucoma in the study eye * Prior glaucoma surgery in the study eye * Clinically significant corneal disease * Patients with poor vision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation | 6 months after implantation surgery | Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication |
Countries
India, Panama
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implant MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | implant not received | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Implant |
|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 11.1 |
| primary open-angle glaucoma | 26 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized Black | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 0 Participants |
| Race/Ethnicity, Customized Other | 7 Participants |
| Region of Enrollment India | 10 participants |
| Region of Enrollment Panama | 16 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 26 |
| other Total, other adverse events | 21 / 26 |
| serious Total, serious adverse events | 2 / 26 |
Outcome results
Primary
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication
Time frame: 6 months after implantation surgery
Population: patients who received MINIject implant and were present at both Baseline and 6-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implant | Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation | -8.95 mmHg | Standard Deviation 3.7 |