A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: XEN45 Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. |
Device: XEN45 Glaucoma Treatment System
Ab interno implantation
|
| Active Comparator: Trabeculectomy Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months. |
Procedure: Trabeculectomy
Surgical Intervention
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline (Medicated) in Mean 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 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.
Secondary Outcome Measures
- Percentage of Participants Achieving => 20% Mean IOP Reduction [Baseline to Month 12]
Effectiveness rate is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications with no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
- Change from baseline (medicated) in mean 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.
- Change from baseline in mean 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 success rate is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of intraocular pressure (IOP) without topical glaucoma 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 success rate 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.
Eligibility Criteria
Criteria
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.
-
Medicated 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:
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Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit.
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital /ID# 243994 | Beijing | Beijing | China | 100191 |
| 2 | Xiangya Hospital Central South University /ID# 244599 | Changsha | Hunan | China | 410008 |
| 3 | Jiangsu Province Hospital /ID# 244002 | Nanjing | Jiangsu | China | 210029 |
| 4 | West China Hospital, Sichuan University /ID# 243999 | Chengdu | Sichuan | China | 610041 |
| 5 | The second Affiliated hospital of Zhejiang University school of Medicine /ID# 243996 | Hangzhou | Zhejiang | China | 310009 |
| 6 | Beijing Tongren Hospital, CMU /ID# 244055 | Beijing | China | 100730 | |
| 7 | The First Affiliated Hospital of Fujian Medical University /ID# 244004 | Fuzhou | China | 350005 | |
| 8 | Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843 | Guangzhou | China | 510060 | |
| 9 | Qingdao Eye Hospital of Shandong First Medical University /ID# 243992 | Qingdao | China | 266023 | |
| 10 | Tianjin Eye Hospital /ID# 243997 | Tianjin | China | 300020 | |
| 11 | Eye Hospital, WMU Zhejiang Eye Hospital /ID# 243993 | Wenzhou | China | 325027 | |
| 12 | Xiamen Eye Center of Xiamen University /ID# 244000 | Xiamen | China | 390000 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1924-802-007