Ahmed Glaucoma Valve Surgery With Mitomycin-C

Completed · Phase 2

Conditions studied: Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma, Neovascular Glaucoma

In brief

This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

Key facts

Study ID

NCT02805257

Run by

University of California, San Francisco

People needed

119

Starts

2016-06-01

Expected to finish

2020-03-01

Last updated by the study team

2022-05-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
• Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
• For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.

You may not qualify if…

• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
• Pregnant or nursing women.
• Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
• Patients with nanophthalmos.
• Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
• No light perception vision.
• VA <20/200 in non-study eye.
• Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
• Previous scleral buckling procedure or silicone oil present.
• Uveitic glaucoma.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China
• Shri Ganesh Vinayak Eye Hospital — Raipur, Chhattisgarh, India
• Asociación para Evitar la Ceguera en México (APEC) — Mexico City, Mexico

Full record on ClinicalTrials.gov

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