Study of Exchange of Travoprost Intraocular Implant
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Ocular Safety Measures [12 Months]
Adverse Events including intr-operative and post-operative events (TEAE's)
Secondary Outcome Measures
- Intraocular Pressure [12 Months]
Intraocular Pressure (IOP) in millimeters of Mercury (mmHg)
- Visual Acuity [12 Months]
Corrected Visual Acuity measured from ETDRS Visual Acuity Chart
- Corneal Edema [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Edema (Scale: none, mild, moderate, or severe)
- Corneal Opacity [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Opacity (Scale: none, mild, moderate, or severe)
- Corneal Epithelium [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Epithelium (Normal, or Punctate staining presence)
- Corneal Endothlium [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)
- Anterior Chamber Cells [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)
- Anterior Chamber Flare [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)
- Iris - Neovascularization [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Neovascularization (No, or Yes)
- Iris - Atrophy [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Atrophy (No, or Yes)
- Iris - Pigment Dispersion [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Pigment Dispersion (No, or Yes)
- Pupil [12 Months]
Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Pupil (normal, abnormal)
- Lens Status [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)
- Gonioscopy [12 Months]
Gonioscopy findings of the anterior chamber and angle of the eye
- Specular Microscopy [12 Months]
Specular Microscopy Findings of corneal endothelium
- Dilated Fundus Examination [12 Months]
Dilated Fundus examination performed via ophthalmoscopy including cup-to-disc ratio
- Visual Field [12 Months]
Visual Field changes in Mean Deviation over time (MD of visual field loss)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inland Eye Specialists | Hemet | California | United States | 92545 |
| 2 | North Bath Eye Associates, Inc. | Petaluma | California | United States | 94954 |
| 3 | Eye Center of northern Colorado, PC | Fort Collins | Colorado | United States | 80525 |
| 4 | The Eye Associates of Manatee | Manatee | Florida | United States | 34209 |
| 5 | Ocala Eye | Ocala | Florida | United States | 34471 |
| 6 | Center for Sight | Sarasota | Florida | United States | 34239 |
| 7 | Jones Eye Clinic | Sioux City | Iowa | United States | 51104 |
| 8 | D'Ambrosio Eye Care | Lancaster | Massachusetts | United States | 01523 |
| 9 | Northern New Jersey Eye Institute | South Orange | New Jersey | United States | 07079 |
| 10 | Oklahoma Eye Surgeons | Oklahoma City | Oklahoma | United States | 73112 |
| 11 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
| 12 | Texan Eye | Austin | Texas | United States | 78746 |
| 13 | Lehmann Eye Center | Nacogdoches | Texas | United States | 75965 |
| 14 | Asian Eye Institute | Makati City | Philippines |
Sponsors and Collaborators
- Glaukos Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IDOS-106-EXCH