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

NCT03193736 | Completed Results DMC

• 1 other identifier: ISM04
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

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.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after implantation surgery

Study Arms (1)

implant

EXPERIMENTAL

Device: MINIject implant

Interventions

MINIject implant DEVICE

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.

implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iSTAR Medical: lead

Study Sites (2)

Maxivision Eye Hospital

Hyderabad, Telangana, 500034, India

Location

Clinica de ojos Orillac-Calvo

Panama City, Panama

Location

Related Publications (1)

• 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.

  PMID: 33011690 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Zubair Hussain, VP Clinical and Regulatory Affairs
• Organization: iSTAR Medical

zubair@istarmed.com

+3210771658

Study Officials

• Zubair Hussain, PhD

  iSTAR Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 21, 2017
• Study Start: June 19, 2017
• Primary Completion: April 16, 2018
• Study Completion: November 25, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); PA (1)