Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

VisionCare

Status

Terminated

Conditions

Age Related Macular Degeneration

Treatments

Device: WA-NG (NG-IMT) Telescope Prothesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT04468373

WA-NG-001 EUROPE

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Full description

Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol.

Enrollment

9 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

**The following Inc. & Exc. are sample and not completed list **

Main Exclusion Criteria:

Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement.
Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation
Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS)
Patients must be available for the study duration of 12 months
Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.

Main Exclusion Criteria:

Evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months.
Patients who may require fellow eye cataract extraction and intraocular lens implantation during the 12 months following WA-NG telescope implantation. If fellow eye cataract extraction is anticipated, this procedure should be performed at least 30 days prior to enrollment in the clinical study.
Patients who have had or are expected to have ophthalmic related surgery within the 30 days preceding implantation of the device.
Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation