Age Related Macular DegenerationNCT04468373
Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
A study testing WA-NG (NG-IMT) Telescope Prothesis in people with Age Related Macular Degeneration, run by VisionCare, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- WA-NG (NG-IMT) Telescope Prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- WA-NG (NG-IMT) Telescope Prothesis
- Keywords
- Macular Degeneration, Visual Impairment, Implantable Telescope
- Medical subject headings
- Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WA-NG (NG-IMT) Telescope ProthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| WA-NG (NG-IMT) Telescope Prothesis | Experimental | Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration) Receives: Device: WA-NG (NG-IMT) Telescope Prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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 )
Measured: 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 )
Measured: 12 months
Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
Measured: 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)
Measured: 12 months
Number of Adverse events associated with the implant and use of the device will be evaluated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study startMay 2015
- Primary completionJul 2020
- Study completionJul 2020
Why it stopped: Development of next-generation device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diane Gordon, Study director, VisionCare Ophthalmic Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468373
- Sponsor's protocol ID
- WA-NG-001 EUROPE
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04468373
- Acronym / sponsor ID
- WA-NG-001 EUROPE
- Conditions
- Age Related Macular Degeneration
- Keywords
- Macular Degeneration, Visual Impairment, Implantable Telescope
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of next-generation device
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WA-NG (NG-IMT) Telescope Prothesis | Experimental | Device: WA-NG (NG-IMT) Telescope ProthesisImplantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WA-NG (NG-IMT) Telescope ProthesisThe 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. | Device | WA-NG (NG-IMT) Telescope Prothesis |
Primary outcome
Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
Time frame: 12 months
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)
Time frame: 12 months
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
Time frame: 12 months
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))
Time frame: 12 months
Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
Time frame: 12 months
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.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Development of next-generation device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Gordon study director
VisionCare Ophthalmic Technologies
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WA-NG (NG-IMT) Telescope Prothesis in people with Age Related Macular Degeneration, run by VisionCare, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Development of next-generation device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire) (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.