OAG, Open-angle Glaucoma
Conditions
Keywords
Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP
Brief summary
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. The purpose of this study is to assess adverse events (AEs) and changes in disease activity in participants with open-angle glaucoma (OAG) receiving the XEN45 Glaucoma Treatment System (XEN45). XEN45 is an approved device for the treatment of OAG in participants in China who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (IOP)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. Adult participants with a diagnosis of OAG will be randomized to receive either XEN 45 or trabeculectomy. Around 130 participants will be enrolled in the study at approximately 15 sites in China. Participants will receive XEN45 implanted using the ab interno approach or trabeculectomy on Day 1 and will be followed for 60 months An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Interventions
DEVICEXEN45 Glaucoma Treatment System
Ab interno implantation
PROCEDURETrabeculectomy
Surgical Intervention
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva. * Visible trabecular meshwork with Shaffer angle grade =\> 3 in the study eye at the Screening Visit. * IOP =\> 20 mm Hg and \<= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit.
Exclusion criteria
* Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye. * Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation \[UC3\], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Intraocular Pressure (IOP) | Baseline to Month 12 | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| Number of Participants with Adverse Events (AEs) | Baseline to Month 60 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction | Baseline to Month 12 | Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications without secondary surgical intervention (SSI) for uncontrolled IOP. |
| Change from Baseline in IOP by Visit | Baseline to Month 12 | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| Change from Baseline in Number of Topical IOP-Lowering Medications | Baseline to Month 12 | A numerical count by class of drug of topical IOP lowering medications being taken. |
| Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications | Baseline to Month 12 | The complete treatment response is defined as the percentage of participants achieving IOP \<=18 mm Hg and 20% or more reduction of IOP without topical IOP medications from baseline. |
| Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications | Baseline to Month 12 | The qualified treatment response is defined as the percentage of participants achieving IOP \<= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications. |
Countries
China
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed