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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT02868190
• Date of registration: 11/08/2016
• Prospective Registration: No
• Primary sponsor: Glaukos Corporation
• Public title: Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication
• Scientific title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)
• Date of first enrolment: March 2013
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02868190
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Armenia

Contacts

• Name: Lilit Voskanyan, MD, PhD
• Affiliation: S.V. Malayan Eye Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Open Angle Glaucoma

Intervention(s)

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

Primary Outcome(s)

Mean intraocular pressure reduction of 20% or more vs baseline [Time Frame: 12 months post-op]

Secondary Outcome(s)

Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg [Time Frame: 12 months]

Secondary ID(s)

GCF-038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors