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Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication

Primary Purpose

Open Angle Glaucoma

Status

Completed

Phase

Phase 4

Locations

Armenia

Study Type

Interventional

Intervention

Two trabecular micro-bypass stents (iStent inject)

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:

Screening Exam Inclusion Criteria:

Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs).
Primary open-angle glaucoma (including pigmentary or pseudoexfoliative).
Cup-to-disc ratio ≤ 0.9.
Visual field defects, or nerve abnormality characteristic of glaucoma.
One topical hypotensive medication at time of screening exam.
Intraocular pressure (IOP) > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam.
Study eye BCVA 20/100 or better.
Normal angle anatomy as determined by gonioscopy.
Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent.

Baseline Exam Inclusion Criteria:

Subject has completed appropriate medication washout.
Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period.

EXCLUSION CRITERIA:

Screening Exam Exclusion Criteria:

Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs).
Prior stent implantations (study eye).
Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma.
Prior incisional glaucoma surgery.
Prior SLT within 90 days prior to screening.
Prior ALT.
Iridectomy or laser iridotomy.
Ineligibility for ocular hypotensive medication washout period as determined by the investigator such as: visual field status would be placed at risk by washout period, or unmedicated IOP after washout period would be expected to exceed upper limit of ≥ 38 mmHg.
Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis).
Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata.
Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability.
Corneal opacities or disorders that would inhibit visualization of the nasal angle.
Congenital or traumatic cataract.
Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition.
Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.).
Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis).
Pregnant or nursing women.

Baseline Exam Exclusion Criteria:

Subject did not complete medication washout.
Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout.
Subject did not have a 3mmHg IOP increase over screening mean diurnal IOP.

Sites / Locations

S.V. Malayan's Ophtalmology Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Two micro-bypass stents (iStent inject)

Arm Description

Standalone implantation of two trabecular micro-bypass stents (iStent inject)

Outcomes

Primary Outcome Measures

Mean intraocular pressure reduction of 20% or more vs baseline

Secondary Outcome Measures

Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg

Full Information

NCT ID

NCT02868190

First Posted

August 11, 2016

Last Updated

September 2, 2022

Sponsor

Glaukos Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02868190

Brief Title

Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication

Official Title

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 2013 (Actual)

Primary Completion Date

November 8, 2019 (Actual)

Study Completion Date

November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glaukos Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication

Detailed Description

The study design is as follows: Prospective Subjects with medicated IOP > 18 mmHg and ≤ 30 mmHg Subjects on one topical ocular hypotensive medication prior to stent implantation Implantation of two iStent devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued) IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP Diurnal IOP measurements Follow-up through 60 months postoperative (but could be up to 61 months if subject needs to undergo terminal washout) Descriptive statistics will be tabulated Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion

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

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Two micro-bypass stents (iStent inject)

Arm Type

Other

Arm Description

Standalone implantation of two trabecular micro-bypass stents (iStent inject)

Intervention Type

Device

Intervention Name(s)

Two trabecular micro-bypass stents (iStent inject)

Intervention Description

Standalone implantation of two trabecular micro-bypass stents (iStent inject)

Primary Outcome Measure Information:

Title

Mean intraocular pressure reduction of 20% or more vs baseline

Time Frame

12 months post-op

Secondary Outcome Measure Information:

Title

Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Screening Exam Inclusion Criteria: Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs). Primary open-angle glaucoma (including pigmentary or pseudoexfoliative). Cup-to-disc ratio ≤ 0.9. Visual field defects, or nerve abnormality characteristic of glaucoma. One topical hypotensive medication at time of screening exam. Intraocular pressure (IOP) > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam. Study eye BCVA 20/100 or better. Normal angle anatomy as determined by gonioscopy. Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent. Baseline Exam Inclusion Criteria: Subject has completed appropriate medication washout. Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period. EXCLUSION CRITERIA: Screening Exam Exclusion Criteria: Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs). Prior stent implantations (study eye). Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders. Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma. Prior incisional glaucoma surgery. Prior SLT within 90 days prior to screening. Prior ALT. Iridectomy or laser iridotomy. Ineligibility for ocular hypotensive medication washout period as determined by the investigator such as: visual field status would be placed at risk by washout period, or unmedicated IOP after washout period would be expected to exceed upper limit of ≥ 38 mmHg. Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis). Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata. Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability. Corneal opacities or disorders that would inhibit visualization of the nasal angle. Congenital or traumatic cataract. Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition. Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease. Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.). Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis). Pregnant or nursing women. Baseline Exam Exclusion Criteria: Subject did not complete medication washout. Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout. Subject did not have a 3mmHg IOP increase over screening mean diurnal IOP.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilit Voskanyan, MD, PhD

Organizational Affiliation

S.V. Malayan Eye Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

S.V. Malayan's Ophtalmology Centre

City

Yerevan

ZIP/Postal Code

375108

Country

Armenia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27739003

Citation

Lindstrom R, Lewis R, Hornbeak DM, Voskanyan L, Giamporcaro JE, Hovanesian J, Sarkisian S. Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up. Adv Ther. 2016 Nov;33(11):2082-2090. doi: 10.1007/s12325-016-0420-8. Epub 2016 Oct 13.

Results Reference

background

PubMed Identifier

32021070

Citation

Lindstrom R, Sarkisian SR, Lewis R, Hovanesian J, Voskanyan L. Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication. Clin Ophthalmol. 2020 Jan 13;14:71-80. doi: 10.2147/OPTH.S235293. eCollection 2020.

Results Reference

derived

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Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication

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