Trial Outcomes & Findings for MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications (NCT NCT03193736)
NCT ID: NCT03193736
Last Updated: 2021-02-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
6 months after implantation surgery
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Received Implant
|
25
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
implant not received
|
1
|
Baseline Characteristics
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Baseline characteristics by cohort
| Measure |
Implant
n=26 Participants
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.
|
|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
Panama
|
16 participants
n=99 Participants
|
|
Region of Enrollment
India
|
10 participants
n=99 Participants
|
|
primary open-angle glaucoma
|
26 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 months after implantation surgeryPopulation: patients who received MINIject implant and were present at both Baseline and 6-month follow-up visit
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
Outcome measures
| Measure |
Implant
n=24 Participants
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.
|
|---|---|
|
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
|
-8.95 mmHg
Standard Deviation 3.7
|
Adverse Events
Implant
Serious events: 2 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Implant
n=26 participants at risk
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.
|
|---|---|
|
General disorders
death
|
3.8%
1/26 • Number of events 1 • 2 years post-implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic carcinoma
|
3.8%
1/26 • Number of events 1 • 2 years post-implantation
|
Other adverse events
| Measure |
Implant
n=26 participants at risk
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.
|
|---|---|
|
Eye disorders
Anterior Chamber inflammation
|
30.8%
8/26 • Number of events 8 • 2 years post-implantation
|
|
Eye disorders
Visual acuity reduced
|
30.8%
8/26 • Number of events 9 • 2 years post-implantation
|
|
Nervous system disorders
Visual Field Defect
|
26.9%
7/26 • Number of events 7 • 2 years post-implantation
|
|
Investigations
Intraocular Pressure increased
|
19.2%
5/26 • Number of events 6 • 2 years post-implantation
|
|
Eye disorders
Lenticular opacities
|
19.2%
5/26 • Number of events 5 • 2 years post-implantation
|
|
Injury, poisoning and procedural complications
Hyphaema
|
11.5%
3/26 • Number of events 4 • 2 years post-implantation
|
|
Eye disorders
Conjunctival haemorrhage
|
7.7%
2/26 • Number of events 2 • 2 years post-implantation
|
|
Eye disorders
eye pain
|
7.7%
2/26 • Number of events 2 • 2 years post-implantation
|
|
Eye disorders
eye pruritus
|
7.7%
2/26 • Number of events 2 • 2 years post-implantation
|
Additional Information
Zubair Hussain, VP Clinical and Regulatory Affairs
iSTAR Medical
Phone: +3210771658
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * first publication to be made by Sponsor as part of publication of results obtained from all sites participating in the study * intended manuscript to be submitted to Sponsor for review min 60 days in advance, proposals for changes submitted by Sponsor to be taken into consideration by Principal Investigator, unless they interfere with scientific nature or neutrality of the publication * Sponsor may demand postponement of publication by max 90 days to protect intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER