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MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Sponsor
iSTAR Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT03374553
Collaborator
(none)
52
Enrollment
3
Locations
2
Arms
38.5
Actual Duration (Months)
17.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the efficacy and safety of MINIject 636 and 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.

Condition or Disease Intervention/Treatment Phase
  • Device: MINI DO636
  • Device: MINI SO636
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Actual Study Start Date :
Nov 25, 2017
Actual Primary Completion Date :
Jan 17, 2019
Actual Study Completion Date :
Feb 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: MINIject DO Integrated System CS636 (MINI DO636)

MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).

Device: MINI DO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
Experimental: MINIject SO Integrated System CS636 (MINI SO636)

MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Single Operator Delivery Tool (SODT).

Device: MINI SO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).

Outcome Measures

Primary Outcome Measures

  1. Reduction in medicated diurnal IOP [6 months after surgery]

    DODT/SODT arm will be evaluated separately

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clínica Oftalmológica del Caribe Barranquilla Colombia
2 Maxivision Eye Hospital Hyderabad Telangana India 500034
3 Panama Eye Center Panama city Panama

Sponsors and Collaborators

  • iSTAR Medical

Investigators

  • Study Director: Zubair Hussain, PhD, iSTAR Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iSTAR Medical
ClinicalTrials.gov Identifier:
NCT03374553
Other Study ID Numbers:
  • ISM05
First Posted:
Dec 15, 2017
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Apr 22, 2022