Primary Open Angle Glaucoma
Conditions
Keywords
POAG
Brief summary
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.
Detailed description
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.
Interventions
PROCEDUREGlaucoma Surgery
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.
DEVICEInnFocus MicroShunt
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Sponsors
InnFocus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
- POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg -
Exclusion criteria
- Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure | 12 months | The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up |
| Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure | 24 months | The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal Intraocular Pressure Change | 12 months | Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months. |
| Number of Participants With Postoperative Interventions at 12 Months | 12 months | The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit. |
| Participants With Postoperative Interventions at 24 Months | 24 months | The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit. |
Countries
France, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
This report presents data for 527 out of 732 patients who were enrolled in the INN-005 study and who were either randomized to the MicroShunt or Trabeculectomy.
Participants by arm
| Arm | Count |
|---|---|
| InnFocus MicroShunt InnFocus MicroShunt
InnFocus MicroShunt: An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure. | 395 |
| Trabeculectomy glaucoma surgery to reduce IOP
Glaucoma Surgery: An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure. | 132 |
| Total | 527 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 5 | 1 |
| Overall Study | General Anesthesia panic attack | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 2 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Subject randomized after study treatment cut off | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | InnFocus MicroShunt | Total | Trabeculectomy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 231 Participants | 312 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 164 Participants | 215 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 82 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 311 Participants | 424 Participants | 113 Participants |
| Region of Enrollment France | 12 Participants | 14 Participants | 2 Participants |
| Region of Enrollment Italy | 10 Participants | 13 Participants | 3 Participants |
| Region of Enrollment Netherlands | 13 Participants | 18 Participants | 5 Participants |
| Region of Enrollment Spain | 13 Participants | 17 Participants | 4 Participants |
| Region of Enrollment United Kingdom | 10 Participants | 15 Participants | 5 Participants |
| Region of Enrollment United States | 337 Participants | 450 Participants | 113 Participants |
| Sex: Female, Male Female | 214 Participants | 273 Participants | 59 Participants |
| Sex: Female, Male Male | 181 Participants | 254 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 395 | 1 / 131 |
| other Total, other adverse events | 366 / 395 | 122 / 131 |
| serious Total, serious adverse events | 13 / 395 | 3 / 131 |
Outcome results
Primary
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
Time frame: 24 months
Population: Primary Effectiveness Endpoint at 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InnFocus MicroShunt | Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure | 200 Participants |
| Trabeculectomy | Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure | 85 Participants |
Primary
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Time frame: 12 months
Population: Primary Effectiveness Endpoint at 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InnFocus MicroShunt | Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure | 216 Participants |
| Trabeculectomy | Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure | 96 Participants |
Secondary
Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.
Time frame: 12 months
Population: Intent-to-treat (ITT) Population consisted of 527 randomized subjects and was population for Primary Effectiveness Endpoint/Secondary Effectiveness Endpoint #2. 395 in MicroShunt group and 132 in Trab. Secondary Effectiveness Endpoint #1 based on Glaucoma Reoperation Censored Subpopulation ITT Population which is why numbers differ. Glaucoma Reoperation Censored Subpopulation (subject data excluded from date of a qualifying glaucoma reoperation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InnFocus MicroShunt | Mean Diurnal Intraocular Pressure Change | -6.46 mmHg | Standard Deviation 5.56 |
| Trabeculectomy | Mean Diurnal Intraocular Pressure Change | -9.80 mmHg | Standard Deviation 5.92 |
Secondary
Mean Diurnal Intraocular Pressure Change
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
Time frame: 24 months
Population: Intent-to-treat (ITT) Population consisted of 527 randomized subjects and was population for Primary Effectiveness Endpoint/Secondary Effectiveness Endpoint #2. 395 in MicroShunt group and 132 in Trab. Secondary Effectiveness Endpoint #1 based on Glaucoma Reoperation Censored Subpopulation ITT Population which is why numbers differ. Glaucoma Reoperation Censored Subpopulation (subject data excluded from date of a qualifying glaucoma reoperation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InnFocus MicroShunt | Mean Diurnal Intraocular Pressure Change | -6.55 mmHg | Standard Deviation 5.47 |
| Trabeculectomy | Mean Diurnal Intraocular Pressure Change | -9.85 mmHg | Standard Deviation 5.48 |
Secondary
Number of Participants With Postoperative Interventions at 12 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.
Time frame: 12 months
Population: To show Postoperative Interventions at 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InnFocus MicroShunt | Number of Participants With Postoperative Interventions at 12 Months | 161 Participants |
| Trabeculectomy | Number of Participants With Postoperative Interventions at 12 Months | 89 Participants |
Secondary
Participants With Postoperative Interventions at 24 Months
The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.
Time frame: 24 months
Population: To show Postoperative Interventions at 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InnFocus MicroShunt | Participants With Postoperative Interventions at 24 Months | 219 Participants |
| Trabeculectomy | Participants With Postoperative Interventions at 24 Months | 93 Participants |