NCT02805257

Ahmed Glaucoma Valve Surgery With Mitomycin-C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.

Conditions

• Glaucoma
• Primary Open Angle Glaucoma
• Secondary Glaucoma
• Neovascular Glaucoma

Interventions

Type	Name	Description
DRUG	Mitomycin-C	Intraoperative and postoperative injections of mitomycin-c/Mitosol
OTHER	Balanced Salt Solution	Intraoperative and postoperative injections of BSS
PROCEDURE	Ahmed Glaucoma Valve Implant	Implantation of Ahmed Valve in study eye

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2016-06-17
• Last updated: 2022-05-31
• Results posted: 2022-05-31

Locations

4 sites across 4 countries: United States, China, India, Mexico

Regulatory

• FDA-regulated drug study