Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Secondary Glaucoma; Glaucoma; Primary Open Angle Glaucoma; Neovascular Glaucoma

Treatments: Procedure: Ahmed Glaucoma Valve Implant; Drug: Mitomycin-C; Other: Balanced Salt Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02805257

IRB#16-18935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 2 patient groups, including a placebo group

Mitomycin-C

Experimental group

Description:

0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.

Treatment:

Drug: Mitomycin-C

Procedure: Ahmed Glaucoma Valve Implant

Balanced Salt Solution (BSS)

Placebo Comparator group

Description:

0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.

Treatment:

Other: Balanced Salt Solution

Procedure: Ahmed Glaucoma Valve Implant