Primary Open Angle Glaucoma
Conditions
Keywords
glaucoma shunt, glaucoma drainage device
Brief summary
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients
Detailed description
The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.
Interventions
DEVICEInnFocus MicroShunt implantation
Implantation will include the use of Mitomycin C applied with sponges.
Sponsors
InnFocus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery. 2. Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos: 1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles. 2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles. 3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue. 4. Disc rim or peripapillary retinal nerve fiber layer hemorrhages. 4\) Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form
Exclusion criteria
1. Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results. 2. Iridocorneal endothelial syndrome. 3. Epithelial or fibrous downgrowth. 4. Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc. 5. Chronic ocular inflammatory disease. 6. Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment. 7. Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.). 8. Severe anterior or posterior blepharitis. 9. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment. 10. Prior laser peripheral iridotomy. 11. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA) 12. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1. 13. Previous cyclodestructive procedure. 14. Use of oral hypotensive glaucoma medications for treatment of the fellow eye. 15. Severe anterior or posterior blepharitis. 16. Unwilling to discontinue contact lens use after surgery. 17. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment. 18. Presence of an anterior chamber IOL (AC-IOL). 19. Prior laser peripheral iridotomy. 20. Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period. 21. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA) 22. Known allergy or other contraindication to Mitomycin C (MMC) drug. 23. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1. 24. Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring). 25. Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization). 26. Central corneal thickness that is less than 450 microns or greater than 620 microns. 27. Previous cyclodestructive procedure. 28. Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole. 29. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease. 30. Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.) 31. Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits), 1. inability to reliably complete visual field testing over the course of the study, 2. uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study. 3. Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease), 4. inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions. 5. immunodeficiency concerns. 6. known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen. 32. Intraocular silicone oil. 33. Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.) 34. Chemotherapy within six months of the screening visit. 35. Use of oral hypotensive glaucoma medications for treatment of the fellow eye. 36. A requirement of general anesthesia for the procedure. 37. Bacterial conjunctivitis 38. Bacterial corneal ulcers 39. Endophthalmitis 40. Orbital cellulitis 41. Bacteremia or septicemia 42. Active scleritis 43. Uveitis 44. Severe dry eye syndrome 45. Severe myopia 46. Pseudo-exfoliative glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Study Success | Month 6, 9, 12, and 24 | Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP Change | Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24 | IOP relative to the pre-operative value was assessed at each post-operative visit (Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Supplemental Medical Therapy at M12 and M24 | 12 and 24 Months | Throughout the study, the number of glaucoma supplemental medications (derived as the number of medication classes) required after the IMS procedure. |
Countries
France, Netherlands, Spain, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Suffering From Primary Open Angle Glaucoma Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Excl. #31 Ocular pathology or medical condition which would place subject at increased risk | 1 |
| Overall Study | Excluded by Sponsor - other reason | 2 |
| Overall Study | Excluded for medical reasons | 2 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Subjects Suffering From Primary Open Angle Glaucoma | — |
|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 12.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 65 Participants | — |
| Region of Enrollment Netherlands | 12 Participants | — |
| Region of Enrollment Spain | 16 Participants | — |
| Region of Enrollment Switzerland | 8 Participants | — |
| Sex: Female, Male Female | 53 Participants | — |
| Sex: Female, Male Male | 48 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 107 |
| other Total, other adverse events | 67 / 107 |
| serious Total, serious adverse events | 11 / 107 |
Outcome results
Primary
Number of Participants With Study Success
Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population
Time frame: Month 6, 9, 12, and 24
Population: The Intent-to-Treat (ITT) population included all patients who have signed the informed consent and received the assigned therapy under evaluation (InnFocus MicroShunt).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Success With Respect for IOP | Number of Participants With Study Success | Month 6 | 62 Participants |
| Success With Respect for IOP | Number of Participants With Study Success | Month 9 | 59 Participants |
| Success With Respect for IOP | Number of Participants With Study Success | Month 12 | 58 Participants |
| Success With Respect for IOP | Number of Participants With Study Success | Month 24 | 60 Participants |
Secondary
IOP Change
IOP relative to the pre-operative value was assessed at each post-operative visit (Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24).
Time frame: Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24
Population: The Intent-to-Treat (ITT) population included all patients who have signed the informed consent and received the assigned therapy under evaluation (InnFocus MicroShunt).~IOP data collected after glaucoma re-operation was censored for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Success With Respect for IOP | IOP Change | Baseline | 21.5 mmHg | Standard Deviation 4.2 |
| Success With Respect for IOP | IOP Change | Day 1 | 9.5 mmHg | Standard Deviation 2.9 |
| Success With Respect for IOP | IOP Change | Day 7 | 9.8 mmHg | Standard Deviation 3.5 |
| Success With Respect for IOP | IOP Change | Week 4 | 12.8 mmHg | Standard Deviation 6 |
| Success With Respect for IOP | IOP Change | Month 3 | 14 mmHg | Standard Deviation 5.2 |
| Success With Respect for IOP | IOP Change | Month 6 | 15 mmHg | Standard Deviation 4.7 |
| Success With Respect for IOP | IOP Change | Month 9 | 15.3 mmHg | Standard Deviation 6.6 |
| Success With Respect for IOP | IOP Change | Month 12 | 15 mmHg | Standard Deviation 4 |
| Success With Respect for IOP | IOP Change | Month 24 | 14 mmHg | Standard Deviation 3 |
Other Pre-specified
Number of Participants Requiring Supplemental Medical Therapy at M12 and M24
Throughout the study, the number of glaucoma supplemental medications (derived as the number of medication classes) required after the IMS procedure.
Time frame: 12 and 24 Months
Population: Patients Taking Glaucoma Supplemental Treatment (Study Eye) ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Success With Respect for IOP | Number of Participants Requiring Supplemental Medical Therapy at M12 and M24 | 25 Participants |
| Need for Glaucoma Supplemental Treatment at M24 | Number of Participants Requiring Supplemental Medical Therapy at M12 and M24 | 25 Participants |