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

February 3, 2023 updated by: Neurotech Pharmaceuticals

A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Royal Victorian Eye and Ear Hospital Research and Ethics Committee
  • Germany
      • Bonn, Germany, 53127
        • Universitäts Klinikum Bonn
      • Freiburg, Germany, 79106
        • Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien
      • Münster, Germany, 48145
        • St. Franziskus Hospital
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado, P.C.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Eye Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Department of Ophthalmology
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan, Kellogg Eye Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Retina Institute
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Strong Memorial Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44122
        • Retina Associates of Cleveland, INC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultants
    • Oregon
      • Portland, Oregon, United States, 97210
        • Retina Northwest, P.C. - Sylvan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Southeastern Retina Associates, PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center, PLLC
      • Grapevine, Texas, United States, 76051
        • Retina Center of Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham
Procedure: Sham
Non-penetrating sham procedure to mimic implant procedure.
EXPERIMENTAL: NT-501
Combination product: NT-501
Surgery to receive one NT-501 device implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Change in Ellipsoid Zone (EZ) Area Loss
Time Frame: Baseline through 24 months.
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.
Baseline through 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Aggregate Sensitivity of Microperimetry
Time Frame: Baseline through 24 months.
NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
Baseline through 24 months.
Mean Change in Reading Speed
Time Frame: Baseline through 24 months.
NT-501 compared to sham relative to mean change in reading speed assessed using Internal Reading Speed Texts (IReST) cards.
Baseline through 24 months.
National Eye Institute-Visual Function Questionnaire (NEI-VFQ)
Time Frame: Baseline through 24 months.
NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.
Baseline through 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurotech Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2018

Primary Completion (ACTUAL)

August 31, 2022

Study Completion (ACTUAL)

September 23, 2022

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTMT-03-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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