Phase 2
N=119
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Glaucoma · Primary Open Angle Glaucoma · Secondary Glaucoma · Neovascular Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02805257 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Intraocular Pressure After Surgery — 13.1; 16.2 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mitomycin-C (Drug); Balanced Salt Solution (Other); Ahmed Glaucoma Valve Implant (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure After Surgery |
14.6; 16.1 | — |
| SECONDARY Intraocular Pressure After Surgery |
14.6; 16.1 | — |
| SECONDARY Number of Medications Postoperatively |
1.2; 1.6 | — |
| SECONDARY Visual Acuity |
12.4; 16 | — |
| SECONDARY Number of Medications Postoperatively |
1.2; 1.6 | — |
| SECONDARY Number of Participants With Intraoperative Complications |
3; 5; 0; 0; 0; 1 | — |
| SECONDARY Visual Acuity |
12.4; 16 | — |
| SECONDARY Number of Participants With Postoperative Complications |
3; 1; 2; 1; 1; 2 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02805257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.