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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03071965
Registration number
NCT03071965
Ethics application status
Date submitted
1/03/2017
Date registered
7/03/2017
Date last updated
9/05/2025
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:
MacTel (Macular Telangiectasia) Type 2
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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
Treatment: Other - 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 for cohort 2 arm were either:
* NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention.
* Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention.
* Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.
Treatment: Other: 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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Treatment: Other
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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) - Cohort 1
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Assessment method [1]
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Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
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Timepoint [1]
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72, 84, 96, and 108 months (based on participants' original implant date during precursor study)
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Primary outcome [2]
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Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
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Assessment method [2]
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Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
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Timepoint [2]
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Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)
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Secondary outcome [1]
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Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
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Assessment method [1]
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Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study.
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Timepoint [1]
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Baseline to 72 Months (based on participants' original implant date)
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Secondary outcome [2]
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Change in BCVA From Baseline for Cohort 1
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Assessment method [2]
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Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date)
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Timepoint [2]
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Baseline to 108 Months (based on participants' original implant date)
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Secondary outcome [3]
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Change in BCVA From Baseline for Cohort 2
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Assessment method [3]
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Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
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Timepoint [3]
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Baseline to 72 Months (based on participants' original implant date)
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Secondary outcome [4]
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Change in Reading Speed From Baseline - Cohort 2 Only
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Assessment method [4]
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Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up. Note: there were
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Timepoint [4]
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Baseline to 72 Months (based on participants' original implant date)
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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
70
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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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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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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 was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02). A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy
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Trial website
https://clinicaltrials.gov/study/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 Aaberg, Jr, MD
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Address
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Neurotech Pharmaceuticals, LLC
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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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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/65/NCT03071965/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/65/NCT03071965/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03071965
Download to PDF