Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

Ivantis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Open Angle Glaucoma

Treatments: Drug: prestudy topical glaucoma medications

Study type: Interventional

Funder types: Industry

Identifiers

NCT03065036

CP-09-001

HYDRUS I (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

Full description

This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.

Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.

Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated intraocular pressure (IOP)
• Diagnosis of mild to advanced open-angle glaucoma
• Shaffer Grade III
• Mental capacity to cooperate when undergoing operative and postoperative examination
• 18 years of age or older
• Provide written informed consent
• Willing and able to return to scheduled follow-up examinations for 24-months

Exclusion criteria

• Closed-angle and narrow-angle forms of glaucoma
• Secondary glaucomas
• Congenital or developmental glaucoma

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Hydrus Aqueous Implant

Experimental group

Description:

Hydrus implanted into Schlemm's Canal.

Treatment:

Drug: prestudy topical glaucoma medications

IOL placement and Hydrus implant

Other group

Description:

Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal

Treatment:

Drug: prestudy topical glaucoma medications