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

NCT02868190 | Completed Phase 4

• 1 other identifier: GCF-038
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean intraocular pressure reduction of 20% or more vs baseline

  12 months post-op

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

Two micro-bypass stents (iStent inject)

OTHER

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

Device: Two trabecular micro-bypass stents (iStent inject)

Interventions

Two trabecular micro-bypass stents (iStent inject) DEVICE

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

Two micro-bypass stents (iStent inject)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

S.V. Malayan's Ophtalmology Centre

Yerevan, 375108, Armenia

Location

Related Publications (2)

• 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.

  PMID: 27739003 BACKGROUND

• 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.

  PMID: 32021070 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Lilit Voskanyan, MD, PhD

  S.V. Malayan Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: March 1, 2013
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)