End Stage Macular DegenerationNCT00555165
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
A study testing Telescope prosthesis in people with End Stage Macular Degeneration, run by VisionCare, Inc. at 4 sites in United Kingdom.
Trial summary
Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- End Stage Macular Degeneration
- What is being tested?
- Telescope prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Nov 2007to May 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CE Mark approved indication of use which includes
- At least 55 years of age
- Bilateral visual impairment due to geographic atrophy or disciform scars
- Evidence of cataract
Who cannot join
- Active CNV (or 'wet' AMD)
- Prior cataract or refractive surgery in the study eye
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Hospitals, Belfast Health & Social Care Trust
Belfast, BT12 6BA
Frimley Park Hospital NHS Trust
Frimley, Surrey, GU167UJ
Moorfields Eye Hospital NHS Trust
London, EC1V 1JN
King's College Hospital NHS Trust
London, SE5 9RS
About this study
Official title: A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)
Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.
- Conditions
- End Stage Macular Degeneration
- Being tested
- Telescope prosthesis
- Keywords
- Macular Degeneration, Visual Impairment, Quality of Life, 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
Monocular implantation of the telescope prosthesis after cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Device: Telescope prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-Corrected Visual Acuity
Measured: 1 year
Secondary outcomes (1)
Quality of Life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuliana Silvestri, MD FRCP FRCS, Principal investigator, Royal Hospitals, Belfast Health & Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555165
- Sponsor's protocol ID
- IMT-UK
- Status last verified
- Nov 2012
- First submitted
- 5 Nov 2007
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)
- ClinicalTrials.gov ID
- NCT00555165
- Acronym / sponsor ID
- IMT-UK
- Conditions
- End Stage Macular Degeneration
- Keywords
- Macular Degeneration, Visual Impairment, Quality of Life, Implantable Telescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Nov 2007 (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.
Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: Telescope prosthesis |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CE Mark approved indication of use which includes
- At least 55 years of age
- Bilateral visual impairment due to geographic atrophy or disciform scars
- Evidence of cataract
Key exclusion criteria (2 listed)
- Active CNV (or 'wet' AMD)
- Prior cataract or refractive surgery in the study eye
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 prosthesisMonocular implantation of the telescope prosthesis after cataract extraction | Device | I |
Primary outcome
Best-Corrected Visual Acuity
Time frame: 1 year
1 secondary outcome
Quality of Life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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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.
Giuliana Silvestri, MD FRCP FRCS principal investigator
Royal Hospitals, Belfast Health & Social Care Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telescope prosthesis in people with End Stage Macular Degeneration, run by VisionCare, Inc. at 4 sites in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Best-Corrected Visual Acuity (time frame: 1 year). 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 14 Nov 2012.