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A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A

Primary Purpose

Macular Telangiectasia Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NT-501
Sham
Sponsored by
Neurotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Telangiectasia Type 2 focused on measuring Ciliary Neurotrophic Factor (CNTF), Macular Telangiectasia (MacTel)

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
  • Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2
  • Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Key Exclusion Criteria:

  • Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
  • Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye
  • Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study
  • Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
  • Participant is pregnant or breastfeeding
  • Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications

Sites / Locations

  • Scripps Clinic Carmel Valley Ambulatory Surgery Center
  • Global Research Foundation
  • Jules Stein Eye Institute / David Geffen School of Medicine
  • Byers Eye Institute at Stanford
  • Bay Area Retina Associates
  • Retina Consultants of Southern Colorado, P.C.
  • Center for Retina and Macular Disease
  • Retina Associates of New Orleans
  • National Institute of Health
  • Cumberland Valley Retina Consultants
  • Associated Retinal Consultants, P.C.
  • Sierra Eye Associates
  • Retina Associates of Cleveland, Inc.
  • Tulsa Retina Consultants
  • Charles Retina Institute
  • Southeastern Retina Associates, PC
  • Texas Retina Associates
  • University of Utah John A. Moran Eye Center
  • Lions Eye Institute
  • Cochin Hospital
  • Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust
  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NT-501

Sham

Arm Description

Outcomes

Primary Outcome Measures

Rate of Change in Ellipsoid Zone (EZ) Area Loss
Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.

Secondary Outcome Measures

Mean Change in Aggregate Sensitivity of Microperimetry
NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
Mean Change in Reading Speed
NT-501 compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.
National Eye Institute-Visual Function Questionnaire (NEI-VFQ)
NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.

Full Information

First Posted
October 3, 2017
Last Updated
February 3, 2023
Sponsor
Neurotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03316300
Brief Title
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
Official Title
A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotech Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Telangiectasia Type 2
Keywords
Ciliary Neurotrophic Factor (CNTF), Macular Telangiectasia (MacTel)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NT-501
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Combination Product
Intervention Name(s)
NT-501
Intervention Description
Surgery to receive one NT-501 device implant.
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Non-penetrating sham procedure to mimic implant procedure.
Primary Outcome Measure Information:
Title
Rate of Change in Ellipsoid Zone (EZ) Area Loss
Description
Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.
Time Frame
Baseline through 24 months.
Secondary Outcome Measure Information:
Title
Mean Change in Aggregate Sensitivity of Microperimetry
Description
NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
Time Frame
Baseline through 24 months.
Title
Mean Change in Reading Speed
Description
NT-501 compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.
Time Frame
Baseline through 24 months.
Title
National Eye Institute-Visual Function Questionnaire (NEI-VFQ)
Description
NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.
Time Frame
Baseline through 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2 Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart Key Exclusion Criteria: Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months Participant is pregnant or breastfeeding Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Chew, MD
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic Carmel Valley Ambulatory Surgery Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Global Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041
Country
United States
Facility Name
Jules Stein Eye Institute / David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Retina Consultants of Southern Colorado, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Retina Associates of New Orleans
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
National Institute of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Associated Retinal Consultants, P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Tulsa Retina Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Utah John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Lions Eye Institute
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A

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