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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InnFocus MicroShunt | Experimental | InnFocus MicroShunt |
|
| Trabeculectomy | Active Comparator | glaucoma surgery to reduce IOP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal Intraocular Pressure Change | Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months. | 12 months |
| Mean Diurnal Intraocular Pressure Change |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Paul Palmberg, M.D., Ph.D. | Bascom Palmer Eye Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Physicians and Surgeons of Arizona | Glendale | Arizona | 85306 | United States | ||
| Arizona Eye Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912740 | Derived | Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3. | |
| 34051211 | Derived | Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | InnFocus MicroShunt | The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC). |
| FG001 | Trabeculectomy | The control group consists of subjects who receive trabeculectomy with MMC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2017 | Jul 8, 2022 |
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|
| InnFocus MicroShunt | Device | 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. |
|
Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
| 24 months |
| 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. | 12 months |
| 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. | 24 months |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Vold Vision | Fayetteville | Arkansas | 72704 | United States |
| University of California at Davis Eye Center | Davis | California | 95817 | United States |
| UCLA Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
| Ophthalmic Consultants of Connecticut | Fairfield | Connecticut | 06824 | United States |
| Inter-Mountain Eye Care | Eagle | Idaho | 83616 | United States |
| Chicago Glaucoma Consultants and CGC Eye Center | Glenview | Illinois | 60026 | United States |
| Eugene and Marilyn Glick Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Stiles Eyecare Excellence | Overland Park | Kansas | 66213 | United States |
| Washington Eye Physicians and Surgeons | Chevy Chase | Maryland | 20815 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| Midwest Eye Surgery Center | Omaha | Nebraska | 68131 | United States |
| New York Eye and Ear Infirmary of Mt. Sinai | New York | New York | 10003 | United States |
| Glaucoma Consultants of the Capital Region | Slingerlands | New York | 12159 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Ophthalmic Surgeons and Consultants of Ohio | Columbus | Ohio | 43215 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Ophthalmic Partners of Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| The Robert Cizik Eye Clinic | Houston | Texas | 77030 | United States |
| Rashid, Rice, Flynn and Reilley Eye Associates | San Antonio | Texas | 78229 | United States |
| Specialty Eye Care | Bellevue | Washington | 98004 | United States |
| Pole Ophtalmologique de la Clinique Mutualiste | Pessac | Bordeaux | 33600 | France |
| Pisa University Hospital Cisanello | Pisa | 56126 | Italy |
| University Eye Clinic Maastricht | Maastricht | 6229 HX | Netherlands |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Primary Effectiveness Endpoint at 12 Months | Posted | Count of Participants | Participants | 12 months |
|
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| 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 | Primary Effectiveness Endpoint at 24 Months | Posted | Count of Participants | Participants | 24 months |
|
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| Secondary | Mean Diurnal Intraocular Pressure Change | Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months. | 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). | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| Secondary | Mean Diurnal Intraocular Pressure Change | Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months | 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). | Posted | Mean | Standard Deviation | mmHg | 24 months |
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| 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. | To show Postoperative Interventions at 12 Months | Posted | Count of Participants | Participants | 12 months |
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| 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. | To show Postoperative Interventions at 24 Months | Posted | Count of Participants | Participants | 24 months |
|
|
Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InnFocus MicroShunt | The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC). | 5 | 395 | 13 | 395 | 366 | 395 |
| EG001 | Trabeculectomy | The control group consists of subjects who receive trabeculectomy with MMC | 1 | 131 | 3 | 131 | 122 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased IOP Requiring Treatment | Eye disorders | MeDra | Systematic Assessment |
| |
| Retinal Complication (Dialysis, Flap Tears, Detachment, Decompression or Proliferative Retinopathy) | Eye disorders | Systematic Assessment |
| ||
| Aqueous Humor Misdirection (malignant glaucoma) | Eye disorders | Systematic Assessment |
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| Choroidal Effusion / Detachment | Eye disorders | Systematic Assessment |
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| Hypotony (IOP < 6mmHg at any Time) | Eye disorders | Systematic Assessment |
| ||
| Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation | Eye disorders | Systematic Assessment |
| ||
| Subconjunctival Bleeding or Hyphema at any time (including Microhyphema) | Eye disorders | Systematic Assessment |
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| Glaucoma Progression with Vision Loss | Eye disorders | Systematic Assessment |
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| Confirmed Worsening in the Visual Field | Eye disorders | Systematic Assessment | Confirmed Worsening in the Visual Field Mean Deviation (MD) of ≥ 2.5 DB compared to MD used to determine Subject Eligibility (confirmed on at least 2 out of 3 Visual Field Tests performed after 3 Months Post Procedure) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased IOP Requiring Treatment | Eye disorders | Systematic Assessment |
| ||
| Hypotony (IOP < 6mmHg at any Time) | Eye disorders | Systematic Assessment |
| ||
| Subconjunctival Bleeding or Hyphema at any time including Microhyphema | Eye disorders | Systematic Assessment |
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| Confirmed Worsening in the Visual Field Mean Deviation | Eye disorders | Systematic Assessment | Confirmed Worsening in the Visual Field Mean Deviation (MD) of ≥ 2.5 DB compared to MD used to determine Subject Eligibility (confirmed on at least 2 out of 3 Visual Field Tests performed after 3 Months Post Procedure) |
| |
| Cataract Progression | Eye disorders | Systematic Assessment |
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| Loss 2 or More Lines of BCVA | Eye disorders | Systematic Assessment | Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation (excluding Posterior Capsule Opacification, followed by post Nd: YAG Capsulotomy and improvement in BCVA) |
| |
| Bleb Leak / Bleb Leak Based on Positive Seidel Test | Eye disorders | Systematic Assessment |
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| Corneal Edema | Eye disorders | Systematic Assessment |
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| Anterior Chamber Cells and/or Flare | Eye disorders | Systematic Assessment |
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| Dry Eye | Eye disorders | Systematic Assessment |
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| Pain | Eye disorders | Systematic Assessment |
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| Blurry Vision | Eye disorders | Systematic Assessment |
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| Shallow Anterior Chamber | Eye disorders | Systematic Assessment |
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| Foreign Body Sensation | Eye disorders | Systematic Assessment |
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| Ptosis | Eye disorders | Systematic Assessment |
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| Bleb Related Complications | Eye disorders | Systematic Assessment |
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| Choroidal Effusion / Detachment | Eye disorders | Systematic Assessment |
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| Diplopia | Eye disorders | Systematic Assessment |
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| Conjunctival Injection / Conjunctival Hyperemia / Conjunctival Inflammation / Conjunctival Scarring | Eye disorders | Systematic Assessment |
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| Encapsulated Bleb | Eye disorders | Systematic Assessment |
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| Ocular Irritation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Herbert, Director of Global Clinical Operations | InnFocus, Inc. (a Santen Company) | (415) 268-9059 | sharon.herbert@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2019 | Jul 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Italy |
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| United Kingdom |
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| France |
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| Spain |
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