Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
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Arizona Advanced Eye Research Institute /ID# 268363, Glendale, Arizona, United States, 85306
LA Glaucoma Group /ID# 268444, Culver City, California, United States, 90232
University Of Colorado - Anschutz Medical Campus /ID# 269947, Aurora, Colorado, United States, 80045
New Vision Eye Center /ID# 269955, Vero Beach, Florida, United States, 32960
Coastal Research Associates - Roswell /ID# 268458, Roswell, Georgia, United States, 30076
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451, Overland Park, Kansas, United States, 66213
Minnesota Eye Consultants - Minneapolis /ID# 272445, Minneapolis, Minnesota, United States, 55431
Vance Thompson Vision - Omaha /ID# 271599, Omaha, Nebraska, United States, 68137
Oklahoma Eye Surgeons /ID# 269174, Oklahoma City, Oklahoma, United States, 73112
Wills Eye Hospital Glaucoma Dept /ID# 268569, Philadelphia, Pennsylvania, United States, 19107
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
45 Years to
ALL
No
AbbVie,
ABBVIE INC., STUDY_DIRECTOR, AbbVie
2028-11