Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Glaucoma; Neovascular Glaucoma; Secondary Glaucoma
• Intervention / Treatment: Drug: Mitomycin-C; Procedure: Ahmed Glaucoma Valve Implant; Other: Balanced Salt Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Zhongshan Ophthalmic Center
• India
  • Chhattisgarh
    • Raipur, Chhattisgarh, India
      • Shri Ganesh Vinayak Eye Hospital
• Mexico
  • Mexico City, Mexico
    • Asociación para Evitar la Ceguera en México (APEC)
• United States
  • California
    • San Francisco, California, United States, 94121
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitomycin-C; 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.	Drug: Mitomycin-C; Intraoperative and postoperative injections of mitomycin-c/Mitosol; Other Names: Mitosol; Procedure: Ahmed Glaucoma Valve Implant; Implantation of Ahmed Valve in study eye
Placebo Comparator: Balanced Salt Solution (BSS); 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.	Procedure: Ahmed Glaucoma Valve Implant; Implantation of Ahmed Valve in study eye; Other: Balanced Salt Solution; Intraoperative and postoperative injections of BSS; Other Names: BSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure After Surgery	Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure After Surgery	Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.	6 months
Number of Medications Postoperatively	Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.	6 months
Visual Acuity	The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.	6 months
Number of Medications Postoperatively	Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.	1 year
Number of Participants With Intraoperative Complications	Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.	Day of Surgery
Visual Acuity	The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.	1 year
Number of Participants With Postoperative Complications	Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.	1 Year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of Colorado, Denver; University of Maryland; Zhongshan Ophthalmic Center, Sun Yat-sen University; Bascom Palmer Eye Institute; Asociación para Evitar la Ceguera en México; University of North Carolina; Hospital Central Militar; Shri Ganesh Vinayak Eye Hospital
• Investigators: Principal Investigator: Ying Han, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: IRB#16-18935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plans to share IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No