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Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)

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 : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Bascom Palmer Eye Institute
University of North Carolina
University of Colorado, Denver
University of Maryland, College Park
Zhongshan Ophthalmic Center, Sun Yat-sen University
Asociación para Evitar la Ceguera en México
Hospital Central Militar
Shri Ganesh Vinayak Eye Hospital
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Primary Open Angle Glaucoma Secondary Glaucoma Neovascular Glaucoma Drug: Mitomycin-C Other: Balanced Salt Solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ahmed Glaucoma Valve Surgery With Mitomycin-C
Study Start Date : June 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


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 Name: Mitosol

Placebo Comparator: Balanced Salt Solution (BSS)
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Other: Balanced Salt Solution
Intraoperative and postoperative injections of BSS
Other Name: BSS




Primary Outcome Measures :
  1. Intraocular pressure after surgery [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Intraocular pressure after surgery [ Time Frame: 6 months ]
  2. Number of medications postoperatively [ Time Frame: 6 months ]
  3. Complications [ Time Frame: 6 months ]
  4. Endothelial cell count [ Time Frame: 6 months ]
  5. Visual Acuity [ Time Frame: 6 months ]
  6. Number of medications [ Time Frame: 1 year ]
  7. Complications [ Time Frame: 1 year ]
  8. Endothelial cell count [ Time Frame: 1 year ]
  9. Visual acuity [ Time Frame: 1 year ]


Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of California, San Francisco
Bascom Palmer Eye Institute
University of North Carolina
University of Colorado, Denver
University of Maryland, College Park
Zhongshan Ophthalmic Center, Sun Yat-sen University
Asociación para Evitar la Ceguera en México
Hospital Central Militar
Shri Ganesh Vinayak Eye Hospital
Investigators
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Principal Investigator: Ying Han, MD, PhD University of California, San Francisco
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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: December 20, 2019
Last Verified: December 2019

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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
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors