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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03071965




Registration number
NCT03071965
Ethics application status
Date submitted
1/03/2017
Date registered
7/03/2017
Date last updated
14/05/2021

Titles & IDs
Public title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Scientific title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Secondary ID [1] 0 0
NTMT-01/02E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Telangiectasia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ellipsoid zone (area of IS/OS loss) - Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2
Timepoint [1] 0 0
36, 48, 60, and 72 months
Primary outcome [2] 0 0
Ellipsoid zone (area of IS/OS loss) - Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1
Timepoint [2] 0 0
72, 84, 96, and 108 months
Secondary outcome [1] 0 0
Retinal sensitivity (dB) - Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2
Timepoint [1] 0 0
36, 48, 60, and 72 months
Secondary outcome [2] 0 0
Retinal sensitivity (dB) - Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1
Timepoint [2] 0 0
72, 84, 96, and 108 months
Secondary outcome [3] 0 0
Increase in ellipsoid zone (area of IS/OS loss) - Proportion of study eyes with a 35% or more increase from baseline at 36, 48, 60, and 72 months for Cohort 2
Timepoint [3] 0 0
36, 48, 60, and 72 months
Secondary outcome [4] 0 0
Increase in ellipsoid zone (area of IS/OS loss) - Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1
Timepoint [4] 0 0
72, 84, 96, and 108 months
Secondary outcome [5] 0 0
Visual acuity - Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2
Timepoint [5] 0 0
36, 48, 60, and 72 months
Secondary outcome [6] 0 0
Visual acuity - Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1
Timepoint [6] 0 0
72, 84, 96, and 108 months
Secondary outcome [7] 0 0
Visual acuity - Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
Timepoint [7] 0 0
36, 48, 60, and 72 months
Secondary outcome [8] 0 0
Visual acuity - Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
Timepoint [8] 0 0
72, 84, 96, and 108 months
Secondary outcome [9] 0 0
Visual acuity - Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
Timepoint [9] 0 0
36, 48, 60, and 72 months
Secondary outcome [10] 0 0
Visual acuity - Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
Timepoint [10] 0 0
72, 84, 96, and 108 months
Secondary outcome [11] 0 0
Reading speed - Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2
Timepoint [11] 0 0
36, 48, 60, and 72 months
Secondary outcome [12] 0 0
Reading speed - Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1
Timepoint [12] 0 0
72, 84, 96, and 108 months

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.
Minimum age
21 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There are no Exclusion Criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [3] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neurotech Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03071965
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Hohman, PhD
Address 0 0
Neurotech Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications