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Age-related Macular DegenerationTESNCT03011554

Telescope Exchange Study

A study testing Implantable Miniature Telescope (IMT) in people with Age-related Macular Degeneration, run by VisionCare, Inc. at 14 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular… 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?
Implantable Miniature Telescope (IMT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
14 sitesUnited States
Study dates
22 Mar 2017to 31 Dec 2022
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

  • Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by FA
  • Be age 65 or older
  • Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart
  • Be pseudophakic in the eye selected for telescope implantation
  • Agree to undergo pre-surgery training with a low vision specialist
  • Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
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  • Agree to participate in postoperative vision training with a low vision specialist.
  • Patients must be able to provide and sign a voluntary informed consent.
  • Patients must not meet any of the exclusion criteria below.

Who cannot join

  • Stargardt's macular dystrophy
  • Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device.
  • Any ophthalmic pathology that compromises fellow-eye peripheral vision
  • A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP >22mmHg while on maximum medication
  • Known sensitivity to planned study concomitant medications.
  • An ocular condition that predisposes the patient to eye rubbing.
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  • Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
  • Operative eye with:
  • Evidence of active CNV or treatment of CNV within 6 months
  • IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.
  • Central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the IOL.
  • Axial length < 21 mm or >27 mm
  • Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between the ages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, and lower than 1800 cells/mm2 for subjects 75 years old or greater.
  • Corneal stromal or endothelial dystrophies, including guttata
  • History of intraocular or corneal surgery (including DSEK) except cataract removal and IOL placement
  • History of complicated cataract surgery
  • Compromised capsular bag (previous YAG posterior capsulotomy, evidence of tearing)
  • History of Radial Keratotomy
  • Inflammatory ocular disease
  • Pseudoexfoliation or zonular weakness
  • Diabetic retinopathy
  • Untreated retinal tears
  • Retinal vascular disease
  • Optic nerve disease
  • A history of retinal detachment
  • Intraocular tumor
  • Retinitis pigmentosa
  • Prior or expected ophthalmic related surgery within 30 days preceding telescope implantation
  • Any medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation in the study

Trial locations and contacts

14 sites in 1 country.

Carole Schreier contact

(408) 329-9134

carole@visioncareinc.net

Diane Gordon contact

+972-3-928-4002

diane@visioncareinc.net

14 sites in 1 country

United States14 sites, 14 recruiting

  • Eye Associates of New Mexico Vision Research Center

    Albuquerque, New Mexico, 87109

    Gregory Ogawa, Dr., 505-888-5757

    Tegan VandenBosch, 505.348-9393, tvandenbosch@lrri.org

    Recruiting

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

    Munira Hussain, 734-647-8397, hussain@umich.edu

    Shahzad Mian, MD

    Recruiting

  • Cornea Consultants of Texas

    Fort Worth, Texas, 76107

    Monica Clark, 817-529-3100 ext. 6, mclark@corneaconsultantstx.com

    Aaleya Korieshi, MD

    Recruiting

  • UC Irvine, Gavin Herbert Eye Institute

    Irvine, California, 92697

    Rosie Magallon, 949-824-8297, rmagallo@uci.edu

    Sumit (Sam) Garg, MD

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Marcia Easterly, 909-558-2732 ext. 22732, MEasterly@llu.edu

    Michael Rauser, MD

    Recruiting

  • Eye Physicians of Long Beach

    Long Beach, California, 90808

    Marisela Silva, 562-421-2757, marisela@eplb.com

    Martha Cazares, (562) 421-2757, marthac@eplb.com

    Recruiting

  • Eye Specialty Group

    Memphis, Tennessee, 38120

    Michael Sanford, 901-685-2200 ext. 683, MichaelSanford@esg.md

    Subba Gollamudi, MD

    Recruiting

  • Minnesota Eye Consultants

    Minnetonka, Minnesota, 55305

    Tessa Hugo, 952-567-6111, Tlhugo@mneye.colm

    Lindsey Fallenstein, (952) 567-6111, lrfallenstein@mneye.com

    Recruiting

  • Retinal Consultants of AZ

    Phoenix, Arizona, 85014

    Ronald Hawkins, 602-222-2221 ext. 1104, rhawkins@retinalconsultantsaz.com

    Derek Kunimoto, MD

    Recruiting

  • Eye Care of San Diego

    San Diego, California, 92103

    Natasha Ozerskiy, 800-765-2737 ext. 133, Natasha@EyeCareofSanDiego.com

    Kim Holdsworth, KimH@eyecareofsandiego.com

    Recruiting

  • Orange County Retina

    Santa Ana, California, 92705

    Marinel Casiano, 714-972-8432, mcasiano@ocretina.net

    Rajiv Rathod, MD

    Recruiting

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

    Peggy Jelemensky, 941-921-5335 ext. 232, SRQresearch@aol.com

    Marc Levy, MD

    Recruiting

  • St. John's Clinic - Eye Specialists. Mercy

    Springfield, Missouri, 65804

    Crystal Trythall, 417-820-7493, Crystal.trythall@mercy.net

    Shachar Tauber, MD

    Recruiting

  • Associated Eye Care

    Stillwater, Minnesota, 55082

    Trish Johnson, 651-275-3077, pjohnson@associatedeyecare.com

    Stephen S Lane, MD

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.

VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD).

Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are currently contraindicated for telescope surgery.

Read more

These patients have no viable therapy available to improve their vision.

The objective of the TES pilot study is to evaluate the safety and effectiveness of implanting the intraocular telescope for improving vision in patients with bilateral end-stage age- related macular degeneration who are pseudophakic.

Being tested
Implantable Miniature Telescope (IMT)
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Miniature Telescope (IMT)Device

    Monocular implantation of the IMT.

Study groups in NCT03011554
Study groupRoleWhat they receive
Implantable Miniature Telescope (IMT)ExperimentalIntervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.
Receives: Device: Implantable Miniature Telescope (IMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    All reported adverse events will be summarized by number and percent of occurence.

    Measured: Subjects will be followed up for three years post implantation

Secondary outcomes (2)

  1. Decrease in best corrected distance visual acuity (BCDVA)

    Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.

    Measured: Subjects will be followed up for three years post implantation

  2. Endothelial Cell Density

    ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.

    Measured: Subjects will be followed up for three years post implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study start22 Mar 2017
  3. Primary completionDec 2019 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011554
Sponsor's protocol ID
IMT-TES-2016
Acronym
TES
Status last verified
Apr 2018
First submitted
2 Jan 2017
Last updated
26 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Implantable Miniature Telescope (IMT) in people with Age-related Macular Degeneration, run by VisionCare, Inc. at 14 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 9 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carole Schreier ((408) 329-9134, carole@visioncareinc.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Subjects will be followed up for three years post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03011554.

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 26 Apr 2018.

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