Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

NCT02873806 | Completed Phase 4

• 1 other identifier: GCF-039
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication

  12 months postoperative

Secondary Outcomes (1)

• Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication

  12 months postoperative

Study Arms (1)

2 micro-bypass stents & travoprost

OTHER

Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone

Procedure: Implantation of two iStent inject micro-bypass stents; Drug: Topical travoprost; Device: Two iStent inject micro-bypass stents; Drug: Tobramycin; Drug: Dexamethasone

Interventions

Implantation of two iStent inject micro-bypass stents PROCEDURE

\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).

Also known as: iStent inject

2 micro-bypass stents & travoprost

Topical travoprost DRUG

\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.

Also known as: travoprost

2 micro-bypass stents & travoprost

Two iStent inject micro-bypass stents DEVICE

\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.

Also known as: iStent inject

2 micro-bypass stents & travoprost

Tobramycin DRUG

Topical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .

2 micro-bypass stents & travoprost

Dexamethasone DRUG

Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): * Week 1: 1 drop four (4) times per day in the study eye * Week 2: 1 drop three (3) times per day in the study eye * Week 3: 1 drop two (2) times per day in the study eye * Week 4: 1 drop one (1) time per day in the study eye

2 micro-bypass stents & travoprost

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)
• C/D ratio ≤ 0.9
• Visual field defects, or nerve abnormality characteristic of glaucoma
• Two topical hypotensive medications at time of screening exam
• 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
• A 3mmHg IOP increase over screening mean IOP

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
• 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.
• 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 that would inhibit visualization of the nasal angle
• Congenital or traumatic cataract
• Retinal or optic nerve disorders 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 (1)

• Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.

  PMID: 28384377 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Travoprost; Tobramycin; Dexamethasone

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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 22, 2016
• Study Start: March 1, 2013
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)