Clinical trial NCT04468373: Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Official title: Study of the WA-NG (NG-IMT) Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-Stage Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Age Related Macular Degeneration
Keywords: Macular Degeneration
Visual Impairment
Implantable Telescope
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
timeFrame: 12 months
measure: Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
timeFrame: 12 months
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire
timeFrame: 12 months
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
timeFrame: 12 months
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
timeFrame: 12 months
measure: Number of Adverse events associated with the implant and use of the device will be evaluated.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Alicante
country: Spain
facility: VISSUM Ophthalmological Corporation
Study officials:
affiliation: VisionCare Ophthalmic Technologies
name: Diane Gordon
role: STUDY_DIRECTOR
References: