Study of Exchange of Travoprost Intraocular Implant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Drug: Travoprost


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Glaucoma status as follows: Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders Corneal status as follows: Any active inflammation or edema 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantation and Exchange<br>Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. | Drug: Travoprost<br>* Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Safety | Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye | 12 Months |