Introduction <p>We conducted a prospective, single-arm, open-label study to evaluate the feasibility and safety of an exchange procedure for the travoprost intracameral implant.</p> Methods <p>Adult subjects with open-angle glaucoma or ocular hypertension who had previously received a travoprost intracameral implant were enrolled at 12 sites in the United States and one in the Philippines. Subjects were administered a new travoprost intracameral implant followed by removal of the previous implant (“exchange” procedure). The primary outcome measures were treatment-emergent adverse events, and other ocular safety parameters (i.e., endothelial cell density, visual acuity, slit-lamp biomicroscopy, and visual fields).</p> Results <p>Thirty-three subjects who had received a travoprost intracameral implant for a mean duration of 4.2&#xa0;years prior were recruited. All subjects were successfully implanted with a new implant, and the previous implant was successfully removed. There were no treatment-related serious adverse events, or severe treatment-related adverse events in the eye that underwent the exchange procedure. No subject required a subsequent explantation.</p> Conclusions <p>Travoprost intracameral implant demonstrated an acceptable safety profile both during and after the exchange procedure, supporting its re-administration.</p> <p>ClinicalTrials.gov NCT04615403.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Safety and Feasibility of the Exchange Procedure for the Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension

  • John P. Berdahl,
  • Robert P. Lehmann,
  • Jason J. Jones,
  • Steven R. Sarkisian Jr.,
  • David Applegate,
  • L. Jay Katz,
  • Angela C. Kothe,
  • Tomas Navratil

摘要

Introduction

We conducted a prospective, single-arm, open-label study to evaluate the feasibility and safety of an exchange procedure for the travoprost intracameral implant.

Methods

Adult subjects with open-angle glaucoma or ocular hypertension who had previously received a travoprost intracameral implant were enrolled at 12 sites in the United States and one in the Philippines. Subjects were administered a new travoprost intracameral implant followed by removal of the previous implant (“exchange” procedure). The primary outcome measures were treatment-emergent adverse events, and other ocular safety parameters (i.e., endothelial cell density, visual acuity, slit-lamp biomicroscopy, and visual fields).

Results

Thirty-three subjects who had received a travoprost intracameral implant for a mean duration of 4.2 years prior were recruited. All subjects were successfully implanted with a new implant, and the previous implant was successfully removed. There were no treatment-related serious adverse events, or severe treatment-related adverse events in the eye that underwent the exchange procedure. No subject required a subsequent explantation.

Conclusions

Travoprost intracameral implant demonstrated an acceptable safety profile both during and after the exchange procedure, supporting its re-administration.

ClinicalTrials.gov NCT04615403.