CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
Mitomycin-C +2 moredrug
Likely dose
Intraoperative and postoperative injections of mitomycin-C (Mitosol)AI-extracted
Key inclusion· 3
  • ✓Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) ≥18 mm Hg
  • ✓Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure
  • ✓For patients with 2 eligible eyes, only the first eligible eye to be implanted is enrolled
Key exclusion· 9
  • ✕Previous cyclodestruction or glaucoma drainage device (GDD) surgery
  • ✕Nanophthalmos
  • ✕Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
  • ✕No light perception vision

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02805257
NCT02805257Phase 2Completed
CompareCT.gov

Ahmed Glaucoma Valve Surgery With Mitomycin-C

University of California, San Francisco·interventional·Posted Jun 17, 2016·Updated May 31, 2022

In Brief

A Phase 2 clinical trial evaluating Mitomycin-C, Balanced Salt Solution, and 1 other intervention for Glaucoma and 3 related conditions. Completed, enrolled 119 participants across 4 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma, Neovascular Glaucoma
CountriesChina, India, Mexico, United States
CollaboratorsBascom Palmer Eye Institute, University of North Carolina, University of Colorado, Denver, University of Maryland, Zhongshan Ophthalmic Center, Sun Yat-sen University, Asociación para Evitar la Ceguera en México, Hospital Central Militar, Shri Ganesh Vinayak Eye Hospital

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 17, 2016
Enrollment StartJun 1, 2016
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.0 years ago

Interventions

Mitomycin-Cdrug

Intraoperative and postoperative injections of mitomycin-c/Mitosol

Balanced Salt Solutionother

Intraoperative and postoperative injections of BSS

Ahmed Glaucoma Valve Implantprocedure

Implantation of Ahmed Valve in study eye