Age Related Macular DegenerationNCT01731964
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
A study testing Telescope prosthesis and WA-NG Telescope Prothesis in people with Age Related Macular Degeneration, run by VisionCare, Inc. at 1 site in Israel.
Trial summary
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis 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?
- Telescope prosthesis and WA-NG Telescope Prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Dec 2015
- 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
Who may be able to join
- Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvment. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator.
Who cannot join
- Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any introcular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis 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. Baseline measurements will include successful use of an external telescope.
Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Telescope prosthesis, WA-NG 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.
Telescope prosthesisDevice
Also called IMT-NG
Monocular implantation of the telescope prosthesis after cataract extraction
WA-NG Telescope ProthesisDevice
The WA-NG telescope prosthesis (Figure 1) 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 Telescope Prothesis | Experimental | Implantable Miniature Telescope for end stage AMD Receives: Device: Telescope prosthesis; Device: WA-NG Telescope Prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Positional stability assessed by slit lamp examination and anterior segment OCT
Measured: 12 months
Secondary outcomes (1)
Safety
adverse events
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 posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: No participants enrolled
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isaac Avni, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731964
- Sponsor's protocol ID
- WA-NG-001 ASSAF HAROFEH
- Status last verified
- Apr 2014
- First submitted
- 14 Nov 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01731964
- Acronym / sponsor ID
- WA-NG-001 ASSAF HAROFEH
- Conditions
- Age Related Macular Degeneration
- Keywords
- Macular Degeneration, Visual Impairment, Implantable Telescope
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Nov 2012 (estimated)
- 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.
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis 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. Baseline measurements will include successful use of an external telescope.
Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.
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 Telescope Prothesis | Experimental | Device: Telescope prosthesis, Device: WA-NG Telescope ProthesisImplantable Miniature Telescope for end stage AMD |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvment. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator.
Key exclusion criteria (1 listed)
- Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any introcular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.
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 |
|---|---|---|
| Telescope prosthesisAlso: IMT-NGMonocular implantation of the telescope prosthesis after cataract extraction | Device | WA- NG Telescope Prothesis |
| WA-NG Telescope ProthesisThe WA-NG telescope prosthesis (Figure 1) 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 Telescope Prothesis |
Primary outcome
Safety
Time frame: 12 months
Positional stability assessed by slit lamp examination and anterior segment OCT
1 secondary outcome
Safety
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Isaac Avni, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telescope prosthesis and WA-NG Telescope Prothesis in people with Age Related Macular Degeneration, run by VisionCare, Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 withdrawn before enrolling participants, so there are no results.
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?
Safety (time frame: 12 months). 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 11 Dec 2014.