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Telescope Exchange Study (TES)

Primary Purpose

Age-related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implantable Miniature Telescope (IMT)
Sponsored by
VisionCare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age-related Macular Degeneration

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Retinal Consultants of AZRecruiting
  • UC Irvine, Gavin Herbert Eye InstituteRecruiting
  • Loma Linda University Medical CenterRecruiting
  • Eye Physicians of Long BeachRecruiting
  • Eye Care of San DiegoRecruiting
  • Orange County RetinaRecruiting
  • Sarasota Retina InstituteRecruiting
  • University of Michigan, Kellogg Eye CenterRecruiting
  • Minnesota Eye ConsultantsRecruiting
  • Associated Eye CareRecruiting
  • St. John's Clinic - Eye Specialists. MercyRecruiting
  • Eye Associates of New Mexico Vision Research CenterRecruiting
  • Eye Specialty GroupRecruiting
  • Cornea Consultants of TexasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantable Miniature Telescope (IMT)

Arm Description

Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2017
Last Updated
April 25, 2018
Sponsor
VisionCare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03011554
Brief Title
Telescope Exchange Study
Acronym
TES
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionCare, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantable Miniature Telescope (IMT)
Arm Type
Experimental
Arm Description
Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.
Intervention Type
Device
Intervention Name(s)
Implantable Miniature Telescope (IMT)
Intervention Description
Monocular implantation of the IMT.
Primary Outcome Measure Information:
Title
Adverse events
Description
All reported adverse events will be summarized by number and percent of occurence.
Time Frame
Subjects will be followed up for three years post implantation
Secondary Outcome Measure Information:
Title
Decrease in best corrected distance visual acuity (BCDVA)
Description
Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
Time Frame
Subjects will be followed up for three years post implantation
Title
Endothelial Cell Density
Description
ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.
Time Frame
Subjects will be followed up for three years post implantation
Other Pre-specified Outcome Measures:
Title
Increase in best corrected distance visual acuity (BCDVA)
Description
Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
Time Frame
Subjects will be followed up for three years post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Schreier
Phone
(408) 329-9134
Email
carole@visioncareinc.net
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Gordon
Phone
+972-3-928-4002
Email
diane@visioncareinc.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumit Garg, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Kunimoto, MD
Organizational Affiliation
Retinal Consultants of AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retinal Consultants of AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Hawkins
Phone
602-222-2221
Ext
1104
Email
rhawkins@retinalconsultantsaz.com
First Name & Middle Initial & Last Name & Degree
Derek Kunimoto, MD
Facility Name
UC Irvine, Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosie Magallon
Phone
949-824-8297
Email
rmagallo@uci.edu
First Name & Middle Initial & Last Name & Degree
Sumit (Sam) Garg, MD
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Easterly
Phone
909-558-2732
Ext
22732
Email
MEasterly@llu.edu
First Name & Middle Initial & Last Name & Degree
Michael Rauser, MD
Facility Name
Eye Physicians of Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisela Silva
Phone
562-421-2757
Email
marisela@eplb.com
First Name & Middle Initial & Last Name & Degree
Martha Cazares
Phone
(562) 421-2757
Email
marthac@eplb.com
First Name & Middle Initial & Last Name & Degree
Carlos E Martinez, MD
First Name & Middle Initial & Last Name & Degree
James W Donovan, MD
Facility Name
Eye Care of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Ozerskiy
Phone
800-765-2737
Ext
133
Email
Natasha@EyeCareofSanDiego.com
First Name & Middle Initial & Last Name & Degree
Kim Holdsworth
Email
KimH@eyecareofsandiego.com
First Name & Middle Initial & Last Name & Degree
John Bokosky, MD
Facility Name
Orange County Retina
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marinel Casiano
Phone
714-972-8432
Email
mcasiano@ocretina.net
First Name & Middle Initial & Last Name & Degree
Rajiv Rathod, MD
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Jelemensky
Phone
941-921-5335
Ext
232
Email
SRQresearch@aol.com
First Name & Middle Initial & Last Name & Degree
Marc Levy, MD
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munira Hussain
Phone
734-647-8397
Email
hussain@umich.edu
First Name & Middle Initial & Last Name & Degree
Shahzad Mian, MD
Facility Name
Minnesota Eye Consultants
City
Minnetonka
State/Province
Minnesota
ZIP/Postal Code
55305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessa Hugo
Phone
952-567-6111
Email
Tlhugo@mneye.colm
First Name & Middle Initial & Last Name & Degree
Lindsey Fallenstein
Phone
(952) 567-6111
Email
lrfallenstein@mneye.com
First Name & Middle Initial & Last Name & Degree
David Hardten, MD
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trish Johnson
Phone
651-275-3077
Email
pjohnson@associatedeyecare.com
First Name & Middle Initial & Last Name & Degree
Stephen S Lane, MD
Facility Name
St. John's Clinic - Eye Specialists. Mercy
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Trythall
Phone
417-820-7493
Email
Crystal.trythall@mercy.net
First Name & Middle Initial & Last Name & Degree
Shachar Tauber, MD
Facility Name
Eye Associates of New Mexico Vision Research Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Ogawa, Dr.
Phone
505-888-5757
First Name & Middle Initial & Last Name & Degree
Tegan VandenBosch
Phone
505.348-9393
Email
tvandenbosch@lrri.org
First Name & Middle Initial & Last Name & Degree
Gregory Ogawa, MD
Facility Name
Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sanford
Phone
901-685-2200
Ext
683
Email
MichaelSanford@esg.md
First Name & Middle Initial & Last Name & Degree
Subba Gollamudi, MD
Facility Name
Cornea Consultants of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Clark
Phone
817-529-3100
Ext
6
Email
mclark@corneaconsultantstx.com
First Name & Middle Initial & Last Name & Degree
Aaleya Korieshi, MD

12. IPD Sharing Statement

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Telescope Exchange Study

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