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Study of Exchange of Travoprost Intraocular Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615403
Recruitment Status : Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Drug: Travoprost Phase 2

Detailed Description:
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: Implantation and Exchange
Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.
Drug: Travoprost
Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision




Primary Outcome Measures :
  1. Ocular Safety Measures [ Time Frame: 12 Months ]
    Adverse Events including intr-operative and post-operative events (TEAE's)


Secondary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 12 Months ]
    Intraocular Pressure (IOP) in millimeters of Mercury (mmHg)

  2. Visual Acuity [ Time Frame: 12 Months ]
    Corrected Visual Acuity measured from ETDRS Visual Acuity Chart

  3. Corneal Edema [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Corneal Edema (Scale: none, mild, moderate, or severe)


  4. Corneal Opacity [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Corneal Opacity (Scale: none, mild, moderate, or severe)


  5. Corneal Epithelium [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Corneal Epithelium (Normal, or Punctate staining presence)


  6. Corneal Endothlium [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Corneal Endothelium (Scale: Normal, 1 fold, 2 folds, 3 folds, 4 folds)


  7. Anterior Chamber Cells [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Anterior Chamber Cells (Scale: <1 cells, 1-5 cells, 6-15 cells, 16-25 cells, 26-50 cells, or >50 cells)


  8. Anterior Chamber Flare [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Anterior Chamber Flare (Scale: None, Faint, Moderate, Marked, Intense)


  9. Iris - Neovascularization [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Iris - Neovascularization (No, or Yes)


  10. Iris - Atrophy [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Iris - Atrophy (No, or Yes)


  11. Iris - Pigment Dispersion [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Iris - Pigment Dispersion (No, or Yes)


  12. Pupil [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Pupil (normal, abnormal)


  13. Lens Status [ Time Frame: 12 Months ]

    Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include:

    Lens Status - phakic/psedophakic; if opacity present grading (Opacity location and severity) graded using the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System (ARLNS) Implant Assessment - (Location, Iris Touch, Endothelial Touch)


  14. Gonioscopy [ Time Frame: 12 Months ]
    Gonioscopy findings of the anterior chamber and angle of the eye

  15. Specular Microscopy [ Time Frame: 12 Months ]
    Specular Microscopy Findings of corneal endothelium

  16. Dilated Fundus Examination [ Time Frame: 12 Months ]
    Dilated Fundus examination performed via ophthalmoscopy including cup-to-disc ratio

  17. Visual Field [ Time Frame: 12 Months ]
    Visual Field changes in Mean Deviation over time (MD of visual field loss)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to attend scheduled follow-up exams for the duration of the study
  • Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
  • Best spectacle corrected visual acuity of 20/80 or better in each eye.
  • Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
  • Angle anatomy defined as follows:

    • Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
    • Normal anatomy as determined by gonioscopy
    • Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of the product at the planned implantation site
  • Able to provide an adequate and interpretable visual field examination result

Exclusion Criteria:

  • Glaucoma status as follows:

    • 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 (original iDose implantation procedure allowed)
    • History of laser iridotomy or laser trabeculoplasty within the last 90 days
  • Corneal status as follows:

    • Any active inflammation or edema (e.g. keratitis, keratoconjunctivitis, keratouveitis)
    • Clinically significant dystrophy (e.g. bullous keratopathy, Fuch's dystrophy)
    • Clinically significant guttata
    • Significant scarring or irregularities (including scars from prior corneal surgery such as PKP (penetrating Keratoplasty), RK (radial keratotomy), etc.), during the course of the study, that may interfere with IOP measurement reliability
    • Opacities or disorders that would inhibit visualization of the nasal angle
  • Congenital or traumatic cataract (except Mittendorf dots)
  • Coroidal detachment, effusion, choroiditis, neovascularization, or any active choroidopathy.
  • Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition, including proliferative diabetic retinopathy (mild background diabetic retinopathy permissible), central retinal artery occlusion, (e.g. presence of numerous large drusen associated with disturbance to or elevation of the retinal pigment epithelium), significant retinal pigment epithelial changes or optic atrophy.
  • Other ocular status as follows:

    • Clinically significant sequelae from trauma (e.g. chemical burns, blunt trauma, etc.)
    • History of chronic ocular inflammatory disease or presence of active ocular inflammation (e.g. uveitis, iritis, iridocyclitis, retinitis, ocular herpes)
    • Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
  • Implantation of Travoprost Intraocular Implant
  • Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
  • Fellow eye status as follows:

    • Fellow eye actively enrolled in this trial or any other clinical trial
  • Subject status as follows:

    • Pregnant or planning to become pregnant during the course of the study
    • Uncontrolled systemic disease (e.g., diabetes, hypertension) that could compromise their participation in the study
    • Current participation in any study or participation within 30 calendar days of Visit 1 (screening)
    • Immunodeficiency conditions
    • Change in an existing chronic systemic therapy that could substantially affect IOP or the study outcomes within 30 days prior to Visit 1 (screening), or anticipated change in such therapy during the study duration
    • Known allergy, hypersensitivity or contraindication to the study medications or their components, namely prostaglandin analogues
    • Any ocular disease or condition that in the opinion of the investigator or Medical Monitor may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. In addition, the investigator or the Medical Monitor may declare any subject ineligible for any sound medical reason
  • The inability to visualize the implantation site via surgical gonioscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615403


Locations
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United States, California
Inland Eye Specialists
Hemet, California, United States, 92545
North Bath Eye Associates, Inc.
Petaluma, California, United States, 94954
United States, Colorado
Eye Center of northern Colorado, PC
Fort Collins, Colorado, United States, 80525
United States, Florida
The Eye Associates of Manatee
Manatee, Florida, United States, 34209
Ocala Eye
Ocala, Florida, United States, 34471
Center for Sight
Sarasota, Florida, United States, 34239
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, Massachusetts
D'Ambrosio Eye Care
Lancaster, Massachusetts, United States, 01523
United States, New Jersey
Northern New Jersey Eye Institute
South Orange, New Jersey, United States, 07079
United States, Oklahoma
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, United States, 73112
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Texan Eye
Austin, Texas, United States, 78746
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
Philippines
Asian Eye Institute
Makati City, Philippines
Sponsors and Collaborators
Glaukos Corporation
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT04615403    
Other Study ID Numbers: IDOS-106-EXCH
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Travoprost
Antihypertensive Agents