Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.

The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: GELA; Device: XEN

Detailed Description

A prospective, randomized, single-blind, positive control design was used to study primary open-angle glaucoma. Eligible subjects were screened and randomly assigned to the experimental group and the control group.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GELA; Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery)	Device: GELA; GELA glaucoma implant
Active Comparator: XEN; Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery).	Device: XEN; XEN gel stent implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate at 6 months after surgery	Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 6 month after surgery.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP reduction	The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.	6 months
topical IOP-lowering medications	Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.	6 months
Success rate 12 months after operation	Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 12 month after surgery.	12 months
Adverse event	Adverse events was recorded and summarized.	12 months

Collaborators and Investigators

• Sponsor: Mingche Biotechnology CO., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2023
• Primary Completion (Estimated): January 12, 2024
• Study Completion (Estimated): July 19, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma Implant
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: MC-001-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No