Macular DegenerationNCT00976235
A Long-Term Monitoring Study of the IMT-002 Patients
A study testing IMT - Implantable Miniature Telescope in people with Macular Degeneration, run by VisionCare, Inc. at 28 sites in United States.
Trial summary
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- IMT - Implantable Miniature Telescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 28 sitesUnited States
- Study dates
- Jun 2006to 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
- Patients must have participated in the IMT-002 trial.
- Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Who cannot join
- Patients who have not participated in the IMT-002 trial.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
W.K. Kellogg Eye Center
Ann Arbor, Michigan, 48105
Emory Eye Center
Atlanta, Georgia, 30322
Wilmer Ophthalmological Institute
Baltimore, Maryland, 21287-9277
Retina Associates of Cleveland
Beachwood, Ohio, 44122
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Southeast Clinical Research
Charlotte, North Carolina, 28210
Retina Group of Washington
Chevy Chase, Maryland, 20815
Kraft Eye Institute
Chicago, Illinois, 60634
Duke University Eye Center
Durham, North Carolina, 27710
Fine, Hoffman & Packer
Eugene, Oregon, 97401
Baylor College of Medicine
Houston, Texas, 77030
Discover Vision Centers
Independence, Missouri, 64055
University of California at Irvine
Irvine, California, 92697
Altos Eye Physician
Los Altos, California, 94024
Doheny Retina Institute - University of Southern California
Los Angeles, California, 90033
Vitreoretinal Foundation
Memphis, Tennessee, 78240
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University
Nashville, Tennessee, 37232
Manhattan Eye & Ear
New York, New York, 10021
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Paducah Retinal Center
Paducah, Kentucky, 42001
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Associated Retinal Consultants
Royal Oak, Michigan, 48073
Medical Center Ophthalmology
San Antonio, Texas, 78240
Sarasota Retinal Institute
Sarasota, Florida, 34239
Associated Eye Care
Stillwater, Minnesota, 55082
Retina Centers P.C.
Tucson, Arizona, 85704
About this study
Official title: Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.
Read the detailed description
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
- Conditions
- Macular Degeneration
- Being tested
- IMT - Implantable Miniature Telescope
- Keywords
- Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis
- 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.
IMT - Implantable Miniature TelescopeDevice
Implantation of the telescope prosthesis (performed under the initial study)
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | Not described Receives: Device: IMT - Implantable Miniature Telescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
Measured: 5 years from implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJun 2006
- 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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976235
- Sponsor's protocol ID
- IMT-002-LTM
- Status last verified
- Nov 2017
- First submitted
- 10 Sep 2009
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
- ClinicalTrials.gov ID
- NCT00976235
- Acronym / sponsor ID
- IMT-002-LTM
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Sep 2009 (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 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.
Detailed description
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Device: IMT - Implantable Miniature Telescope |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have participated in the IMT-002 trial.
- Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Key exclusion criteria (1 listed)
- Patients who have not participated in the IMT-002 trial.
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 |
|---|---|---|
| IMT - Implantable Miniature TelescopeImplantation of the telescope prosthesis (performed under the initial study) | Device | IMT |
Primary outcome
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
Time frame: 5 years from implantation
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 6 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT - Implantable Miniature Telescope in people with Macular Degeneration, run by VisionCare, Inc. at 28 sites in United States.
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 3 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: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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?
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) (time frame: 5 years from implantation). 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 6 Nov 2017.