Ahmed Glaucoma Valve Surgery With Mitomycin-C

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.

Conditions

• Glaucoma
• Primary Open Angle Glaucoma
• Secondary Glaucoma
• Neovascular Glaucoma

Interventions

DRUG

Mitomycin-C

Intraoperative and postoperative injections of mitomycin-c/Mitosol

OTHER

Balanced Salt Solution

Intraoperative and postoperative injections of BSS

PROCEDURE

Ahmed Glaucoma Valve Implant

Implantation of Ahmed Valve in study eye

Sponsors & Collaborators

• Bascom Palmer Eye Institute

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Zhongshan Ophthalmic Center, Sun Yat-sen University

  collaborator OTHER

• Asociación para Evitar la Ceguera en México

  collaborator OTHER

• Hospital Central Militar

  collaborator OTHER_GOV

• Shri Ganesh Vinayak Eye Hospital

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Ying Han, MD, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2020-03-31

Completion

2020-03-31

FDA Drug

Yes

Countries

• United States
• China
• India
• Mexico

Study Locations