A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Primary Purpose
Macular Telangiectasia Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NT-501
Sham
Sponsored by
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
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
- Retina-Vitreous Associates Medical Group
- Retina Consultants of Southern Colorado, P.C.
- Emory University Eye Center
- Northwestern University, Department of Ophthalmology
- Elman Retina Group, PA
- Massachusetts Eye and Ear Infirmary
- New England Retina Consultants
- University of Michigan, Kellogg Eye Center
- Mayo Clinic
- The Retina Institute
- University of Rochester Strong Memorial Hospital
- Cincinnati Eye Institute
- Retina Associates of Cleveland, Inc
- Tulsa Retina Consultants
- Retina Northwest, P.C. - Sylvan
- University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute
- Palmetto Retina Center
- Southeastern Retina Associates, PC
- Retina Research Institute of Texas
- Retina Research Center, PLLC
- Retina Center of Texas
- Retina Consultants of Houston, PA
- Sydney Eye Hospital
- Royal Victorian Eye and Ear Hospital Research and Ethics Committee
- Universitäts Klinikum Bonn
- Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien
- St. Franziskus 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 Internal 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
NCT ID
NCT03319849
First Posted
October 3, 2017
Last Updated
February 3, 2023
Sponsor
Neurotech Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03319849
Brief Title
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
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
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (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
113 (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 Internal 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
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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
Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University, Department of Ophthalmology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Elman Retina Group, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New England Retina Consultants
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Retina Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Rochester Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
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
Retina Northwest, P.C. - Sylvan
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Retina Research Center, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Center of Texas
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital Research and Ethics Committee
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Universitäts Klinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
St. Franziskus Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
12. IPD Sharing Statement
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A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
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