Study of Exchange of Travoprost Intraocular Implant

Glaukos

Status and phase: Completed; Phase 2

Conditions: Open Angle Glaucoma

Treatments: Drug: Travoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT04615403

IDOS-106-EXCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Implantation and Exchange

Experimental group

Description:

Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.

Treatment:

Drug: Travoprost