Back to resultsStudy of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Primary Purpose
Age Related Macular Degeneration
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WA-NG (NG-IMT) Telescope Prothesis
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Macular Degeneration, Visual Impairment, Implantable Telescope
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
Sites / Locations
- Mater Private Hospital
- VISSUM Ophthalmological Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WA-NG (NG-IMT) Telescope Prothesis
Arm Description
Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)
Outcomes
Primary Outcome Measures
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 )
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 )
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 )
Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
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)
Number of Adverse events associated with the implant and use of the device will be evaluated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04468373
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Development of next-generation device
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionCare, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Macular Degeneration, Visual Impairment, Implantable Telescope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WA-NG (NG-IMT) Telescope Prothesis
Arm Type
Experimental
Arm Description
Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)
Intervention Type
Device
Intervention Name(s)
WA-NG (NG-IMT) Telescope Prothesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
Description
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 )
Time Frame
12 months
Title
Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
Description
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 )
Time Frame
12 months
Title
Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire
Description
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 )
Time Frame
12 months
Title
Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
Time Frame
12 months
Title
Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
Description
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)
Time Frame
12 months
Title
Number of Adverse events associated with the implant and use of the device will be evaluated.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Gordon
Organizational Affiliation
VisionCare Ophthalmic Technologies
Official's Role
Study Director
Facility Information:
Facility Name
Mater Private Hospital
City
Dublin
Country
Ireland
Facility Name
VISSUM Ophthalmological Corporation
City
Alicante
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
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