Clinical Trials Logo
  1. Home
  2. Ocular Hypertension
  3. NCT04524416
  4. Details
NCT04524416 Clinical Trial

MINIject Global Long-Term Follow-up Study

Ocular Hypertension Clinical Trial

— STAR-GLOBAL  

Official title:
A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04524416
Other study ID # STAR-GLOBAL (ISM09)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 5, 2020
Est. completion date December 2025

Study information
Verified date May 2023
Source iSTAR Medical
Contact Esma Islamaj, PhD
Phone +32 10 77 12 52
Email esma.islamaj@istarmed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Description:

The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patient who received a MINIject glaucoma implant within a prior clinical study - Patient continues to have MINIject implanted at the point of enrolment - Patient must provide written informed consent to participate Exclusion Criteria: - Individuals under tutorship or trusteeship - Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Minimally invasive glaucoma surgery (MIGS)
MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study.

Locations
Country Name City State
Colombia Clinica Oftalmologica del Caribe Barranquilla
France Center Hospotalier Universitaire Genoble Alpes Grenoble
France Hopital de la Croix-Rousse Lyon
Germany Uniklinik Köln Köln Nordrhein-Westfalen
Germany Universitätsklinikum Mainz Mainz Rheinland Pfalz
Germany Klinikum der Universität München München
India Maxivision Eye Hospital Hyderabad Telangana
Panama Panama Eye Center Panama City
Spain Hospital Clínico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Colombia,  France,  Germany,  India,  Panama,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with serious device-related adverse event in study eye The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation. 5 years post-implantation
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2