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

NCT04468373 | Terminated

• 1 other identifier: WA-NG-001 EUROPE
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 2

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.

Conditions

Age Related Macular Degeneration

Keywords

Macular Degeneration; Visual Impairment; Implantable Telescope

Outcome Measures

Primary Outcomes (6)

• Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)

  Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )

  12 months

• Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)

  Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )

  12 months

• Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire

  Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )

  12 months

• Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))

  12 months

• Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)

  Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)

  12 months

• Number of Adverse events associated with the implant and use of the device will be evaluated.

  12 months

Study Arms (1)

WA-NG (NG-IMT) Telescope Prothesis

EXPERIMENTAL

Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)

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

Interventions

WA-NG (NG-IMT) Telescope Prothesis DEVICE

The WA-NG telescope prosthesis is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.

WA-NG (NG-IMT) Telescope Prothesis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• VisionCare, Inc.: lead

Study Sites (2)

Mater Private Hospital

Dublin, Ireland

Location

VISSUM Ophthalmological Corporation

Alicante, Spain

Location

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diane Gordon

  VisionCare Ophthalmic Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: July 13, 2020
• Study Start: May 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 13, 2020

Record last verified: 2018-12

Locations

ES (1); IE (1)