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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06397131




Registration number
Help: Registration number
NCT06397131
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
29/04/2024
Date registered
Help: Date registered
2/05/2024
Date last updated
Help: Date last updated
5/11/2026

Titles & IDs
Public title
A Study to Determine the Safety and Efficacy of NT-501 With M-CHFM
Scientific title
A Multicenter Study to Determine the Safety and Efficacy of NT-501 Utilizing the Medica Membrane in Macular Telangiectasia Type 2 (MacTel), Including a Randomized Comparative Expansion Cohort
Additional trial identifiers [1] 0 0
NTMT-03C
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Macular Telangiectasia Type 2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Other interventions - M-CHFM
Other interventions - CHFM

Experimental: Cohort 1 (Extension) - M-CHFM - Previously enrolled Cohort 1 participants received M-CHFM and will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason.

Experimental: Cohort 2 (Expansion) - M-CHFM - Participants are randomized 1:1 to receive M-CHFM. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.

Active comparator: Cohort 2 (Expansion) - CHFM - Participants are randomized 1:1 to receive CHFM (US commercially available ENCELTO). Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.


Other interventions: M-CHFM
Single implantation of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM)

Other interventions: CHFM
Single implantation of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM)
Intervention code [1] 0 0
Other interventions
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1 (Extension) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography
Timepoint [1] 0 0
Baseline to 24 months
Primary outcome [2] 0 0
Cohort 2 (Expansion) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography
Timepoint [2] 0 0
Baseline to 12 months
Secondary outcome [1] 0 0
Cohort 1 (Extension) - Incidence of ocular and non-ocular adverse events
Timepoint [1] 0 0
Baseline to 24 months
Secondary outcome [2] 0 0
Cohort 2 (Expansion) - Incidence of ocular and non-ocular adverse events
Timepoint [2] 0 0
Baseline to 12 months
Secondary outcome [3] 0 0
Cohort 1 (Extension) - Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity
Timepoint [3] 0 0
Baseline to 24 months
Secondary outcome [4] 0 0
Cohort 2 (Expansion) - Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity
Timepoint [4] 0 0
Baseline to 12 months

Eligibility
Key inclusion criteria
Inclusion Criteria

To participate in this study, the potential subject and at least 1 of their eyes must meet all of the following criteria:

1. Subjects must have a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500-micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities seen clinically or on SD-OCT.
2. Subject must have a break in the ellipsoid zone (EZ) (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 millimeters squared.
3. Subject's best-corrected visual acuity (BCVA) is 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening.
4. Subject must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality retinal imaging.
5. Subject must be greater than or equal to 21 years of age and less than 80 years of age at screening.
6. Subject or their legally authorized representative must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practices guidelines, and local regulations, before initiating any study-related procedures.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion Criteria

To participate in this study, the potential subject must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):

1. Subject is medically unable to comply with study procedures or follow-up visits.
2. Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
3. Subject 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 therapy in the fellow eye at randomization.
4. Subject 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 (e.g., uncontrolled glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis).
5. Subject has a chronic requirement (e.g., = 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted). The exceptions to this exclusion criteria include artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
6. Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
7. Subject has evidence of intraretinal hyperreflectivity by OCT.
8. Subject has evidence of central serous chorio-retinopathy in either eye.
9. Subject has evidence of pathologic myopia in either eye.
10. Subject has significant corneal or media opacities in either eye.
11. Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
12. Subject has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age -Related Eye Disease Study (AREDS) clinical lens grading system.
13. Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
14. Previous participation in any Neurotech MacTel clinical trial unless the participant: (1) previously consented and screened for a MacTel study but was a screen failure solely due to insufficient lesion size; or (2) has completed participation in the prior Neurotech MacTel study, is not actively enrolled in another Neurotech MacTel study, and has an eligible study eye that was not the study eye in the previous trial.
15. Subject was a participant in any other ocular related or ocular impacted clinical trial of an intervention (drug or device) within the last 6 months.
16. Subject is on chemotherapy.
17. Subject is pregnant or breastfeeding.
18. Subject has a history of malignancy that would compromise the 12-month study survival.
19. Subject with a history of ocular herpes virus in either eye.
20. Subject has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
21. Subject has evidence of subfoveal RPE hyperplasia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/07/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cerulea - East Melbourne
Recruitment hospital [2] 0 0
Lion's Eye Institute - Perth
Recruitment hospital [3] 0 0
Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
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
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Aaberg, Jr., MD
Address 0 0
Neurotech Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Patricia Davis
Address 0 0
Country 0 0
Phone 0 0
401-333-3880
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06397131