STAR-I: MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: implant
|
Device: MINIject 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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maxivision Eye Hospital | Hyderabad | Telangana | India | 500034 |
| 2 | Clinica de ojos Orillac-Calvo | Panama city | Panama |
Sponsors and Collaborators
- iSTAR Medical
Investigators
- Study Director: Zubair Hussain, PhD, iSTAR Medical
Study Documents (Full-Text)
More Information
Publications
None provided.- ISM04
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Implant |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 26 |
| Received Implant | 25 |
| COMPLETED | 21 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Implant |
|---|---|
| Arm/Group Description | 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 Participants | 26 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69.4
(11.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
46.2%
|
| Male |
14
53.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Black |
9
34.6%
|
| Asian |
10
38.5%
|
| Caucasian |
0
0%
|
| Other |
7
26.9%
|
| Region of Enrollment (participants) [Number] | |
| Panama |
16
61.5%
|
| India |
10
38.5%
|
| primary open-angle glaucoma (Count of Participants) | |
| Count of Participants [Participants] |
26
100%
|
Outcome Measures
| Title | Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| patients who received MINIject implant and were present at both Baseline and 6-month follow-up visit |
| Arm/Group Title | Implant |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 24 |
| Mean (Standard Deviation) [mmHg] |
-8.95
(3.7)
|
Adverse Events
| Time Frame | 2 years post-implantation | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Implant | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Implant | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/26 (7.7%) | |
Serious Adverse Events |
||
| Implant | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/26 (7.7%) | |
| General disorders | ||
| death | 1/26 (3.8%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| pancreatic carcinoma | 1/26 (3.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Implant | ||
| Affected / at Risk (%) | # Events | |
| Total | 21/26 (80.8%) | |
| Eye disorders | ||
| Anterior Chamber inflammation | 8/26 (30.8%) | 8 |
| Visual acuity reduced | 8/26 (30.8%) | 9 |
| Lenticular opacities | 5/26 (19.2%) | 5 |
| Conjunctival haemorrhage | 2/26 (7.7%) | 2 |
| eye pain | 2/26 (7.7%) | 2 |
| eye pruritus | 2/26 (7.7%) | 2 |
| Injury, poisoning and procedural complications | ||
| Hyphaema | 3/26 (11.5%) | 4 |
| Investigations | ||
| Intraocular Pressure increased | 5/26 (19.2%) | 6 |
| Nervous system disorders | ||
| Visual Field Defect | 7/26 (26.9%) | 7 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Zubair Hussain, VP Clinical and Regulatory Affairs |
|---|---|
| Organization | iSTAR Medical |
| Phone | +3210771658 |
| zubair@istarmed.com |
- ISM04