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Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

Primary Purpose

Age Related Macular Degeneration

Status
Withdrawn
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Telescope prosthesis
WA-NG Telescope Prothesis
Sponsored by
VisionCare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Macular Degeneration, Visual Impairment, Implantable Telescope

Eligibility Criteria

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

Inclusion Criteria:

  • 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 involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical

Exclusion Criteria:

  • 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 intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WA- NG Telescope Prothesis

Arm Description

Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)

Outcomes

Primary Outcome Measures

Positional Stability
Positional stability assessed by slit lamp examination and anterior segment OCT

Secondary Outcome Measures

Adverse events
adverse events

Full Information

First Posted
May 24, 2011
Last Updated
July 8, 2020
Sponsor
VisionCare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01361256
Brief Title
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Official Title
Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Macular Degeneration, Visual Impairment, Implantable Telescope

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WA- NG Telescope Prothesis
Arm Type
Experimental
Arm Description
Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)
Intervention Type
Device
Intervention Name(s)
Telescope prosthesis
Other Intervention Name(s)
IMT-NG
Intervention Description
Monocular implantation of the telescope prosthesis after cataract extraction
Intervention Type
Device
Intervention Name(s)
WA-NG Telescope Prothesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positional Stability
Description
Positional stability assessed by slit lamp examination and anterior segment OCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical Exclusion Criteria: 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 intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordecai Rosner, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hasomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

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