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MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications (STAR-I)

Primary Purpose

Open Angle Glaucoma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MINIject implant

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
Glaucoma not adequately controlled

Exclusion Criteria:

Diagnosis of glaucoma other than open angle glaucoma
Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
Neovascular glaucoma in the study eye
Prior glaucoma surgery in the study eye
Clinically significant corneal disease
Patients with poor vision

Sites / Locations

Maxivision Eye Hospital
Clinica de ojos Orillac-Calvo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

implant

Arm Description

Outcomes

Primary Outcome Measures

Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation

Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication

Secondary Outcome Measures

Full Information

NCT ID

NCT03193736

First Posted

May 9, 2017

Last Updated

February 8, 2021

Sponsor

iSTAR Medical

1. Study Identification

Unique Protocol Identification Number

NCT03193736

Brief Title

MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Acronym

STAR-I

Official Title

A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 19, 2017 (Actual)

Primary Completion Date

April 16, 2018 (Actual)

Study Completion Date

November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

iSTAR Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

implant

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

MINIject implant

Intervention Description

MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.

Primary Outcome Measure Information:

Title

Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation

Description

Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication

Time Frame

6 months after implantation surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. Glaucoma not adequately controlled Exclusion Criteria: Diagnosis of glaucoma other than open angle glaucoma Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System. Neovascular glaucoma in the study eye Prior glaucoma surgery in the study eye Clinically significant corneal disease Patients with poor vision

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zubair Hussain, PhD

Organizational Affiliation

iSTAR Medical

Official's Role

Study Director

Facility Information:

Facility Name

Maxivision Eye Hospital

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500034

Country

India

Facility Name

Clinica de ojos Orillac-Calvo

City

Panama city

Country

Panama

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33011690

Citation

Denis P, Hirneiss C, Durr GM, Reddy KP, Kamarthy A, Calvo E, Hussain Z, Ahmed IK. Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. Br J Ophthalmol. 2022 Jan;106(1):65-70. doi: 10.1136/bjophthalmol-2020-316888. Epub 2020 Oct 3.

Results Reference

derived

Learn more about this trial

MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

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