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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03071965
Registration number
NCT03071965
Ethics application status
Date submitted
1/03/2017
Date registered
7/03/2017
Date last updated
17/03/2022
Titles & IDs
Public title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
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Scientific title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
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Secondary ID [1]
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NTMT-01/02E
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Telangiectasia
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ciliary neurotrophic factor (CNTF)
Treatment: Surgery - Surgery
Treatment: Surgery - Surgery
Experimental: Cohort 1 - Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
Experimental: Cohort 2 - Participants completed protocol NTMT-02. Participants received surgery to implant NT-501 or sham surgery to mimic implant procedure. Participants that received NT-501 implant were exposed to ciliary neurotrophic factor (CNTF).
Other interventions: Ciliary neurotrophic factor (CNTF)
The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
Treatment: Surgery: Surgery
Surgery to implant device for NT-501
Treatment: Surgery: Surgery
Sham surgery
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ellipsoid zone (area of IS/OS loss)
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Assessment method [1]
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Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2
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Timepoint [1]
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36, 48, 60, and 72 months
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Primary outcome [2]
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Ellipsoid zone (area of IS/OS loss)
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Assessment method [2]
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Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1
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Timepoint [2]
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72, 84, 96, and 108 months
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Secondary outcome [1]
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Retinal sensitivity (dB)
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Assessment method [1]
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Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2
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Timepoint [1]
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36, 48, 60, and 72 months
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Secondary outcome [2]
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Retinal sensitivity (dB)
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Assessment method [2]
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Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1
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Timepoint [2]
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72, 84, 96, and 108 months
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Secondary outcome [3]
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Increase in ellipsoid zone (area of IS/OS loss)
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Assessment method [3]
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Proportion of study eyes with a 35% or more increase from baseline at 36, 48, 60, and 72 months for Cohort 2
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Timepoint [3]
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36, 48, 60, and 72 months
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Secondary outcome [4]
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Increase in ellipsoid zone (area of IS/OS loss)
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Assessment method [4]
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Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1
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Timepoint [4]
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72, 84, 96, and 108 months
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Secondary outcome [5]
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Visual acuity
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Assessment method [5]
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Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2
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Timepoint [5]
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36, 48, 60, and 72 months
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Secondary outcome [6]
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Visual acuity
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Assessment method [6]
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Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1
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Timepoint [6]
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72, 84, 96, and 108 months
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Secondary outcome [7]
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Visual acuity
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Assessment method [7]
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Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
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Timepoint [7]
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36, 48, 60, and 72 months
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Secondary outcome [8]
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Visual acuity
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Assessment method [8]
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Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
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Timepoint [8]
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72, 84, 96, and 108 months
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Secondary outcome [9]
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Visual acuity
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Assessment method [9]
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Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
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Timepoint [9]
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36, 48, 60, and 72 months
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Secondary outcome [10]
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Visual acuity
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Assessment method [10]
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Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
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Timepoint [10]
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72, 84, 96, and 108 months
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Secondary outcome [11]
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Reading speed
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Assessment method [11]
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Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2
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Timepoint [11]
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36, 48, 60, and 72 months
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Secondary outcome [12]
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Reading speed
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Assessment method [12]
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Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1
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Timepoint [12]
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72, 84, 96, and 108 months
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Eligibility
Key inclusion criteria
- Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant
and/or underwent a Sham procedure
- Participant must be offered sufficient opportunity to review and to understand the
informed consent form, agree to the form's contents, and provide written informed
consent.
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Minimum age
21
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- There are no Exclusion Criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/05/2021
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Sydney Eye Hospital - Sydney
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Recruitment hospital [2]
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Centre for Eye Research Australia - East Melbourne
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Recruitment hospital [3]
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Lions Eye Institute - Nedlands
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Ohio
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Country [8]
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United States of America
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State/province [8]
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Neurotech Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a prospective, phase 2 extension study of participants previously enrolled in
NTMT-01 and NTMT-02. This study is designed to evaluate long term safety and efficacy of the
NT-501 implant in participants previously enrolled in the NTMT-01 and NTMT-02 protocols.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03071965
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas Hohman, PhD
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Address
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Neurotech Pharmaceuticals, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03071965
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