Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02805257 |
Recruitment Status :
Completed
First Posted : June 17, 2016
Last Update Posted : July 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Glaucoma Primary Open Angle Glaucoma Secondary Glaucoma Neovascular Glaucoma | Drug: Mitomycin-C Other: Balanced Salt Solution Procedure: Ahmed Glaucoma Valve Implant | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ahmed Glaucoma Valve Surgery With Mitomycin-C |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | March 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Mitomycin-C
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
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Drug: Mitomycin-C
Intraoperative and postoperative injections of mitomycin-c/Mitosol
Other Name: 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.
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Other: Balanced Salt Solution
Intraoperative and postoperative injections of BSS
Other Name: BSS Procedure: Ahmed Glaucoma Valve Implant Implantation of Ahmed Valve in study eye |
- Intraocular pressure after surgery [ Time Frame: 1 year ]
- Intraocular pressure after surgery [ Time Frame: 6 months ]
- Number of medications postoperatively [ Time Frame: 6 months ]
- Complications [ Time Frame: 6 months ]
- Endothelial cell count [ Time Frame: 6 months ]
- Visual Acuity [ Time Frame: 6 months ]
- Number of medications [ Time Frame: 1 year ]
- Complications [ Time Frame: 1 year ]
- Endothelial cell count [ Time Frame: 1 year ]
- Visual acuity [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805257
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94121 | |
China, Guangdong | |
Zhongshan Ophthalmic Center | |
Guangzhou, Guangdong, China | |
India | |
Shri Ganesh Vinayak Eye Hospital | |
Raipur, Chhattisgarh, India | |
Mexico | |
Asociación para Evitar la Ceguera en México (APEC) | |
Mexico City, Mexico |
Principal Investigator: | Ying Han, MD, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02805257 |
Other Study ID Numbers: |
IRB#16-18935 |
First Posted: | June 17, 2016 Key Record Dates |
Last Update Posted: | July 26, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No current plans to share IPD to other researchers. |
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 |
Glaucoma Glaucoma, Open-Angle Glaucoma, Neovascular Ocular Hypertension Eye Diseases Mitomycins Mitomycin |
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