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RecruitingNCT06397131Updated Nov 5, 2026

A Study to Determine the Safety and Efficacy of NT-501 With M-CHFM

A Phase 3 interventional study of M-CHFM and CHFM in Macular Telangiectasia Type 2, sponsored by Neurotech Pharmaceuticals. Recruiting at 6 sites in 2 countries. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Neurotech Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Updated Nov 5, 2026Now RecruitingFirst site in Australia+10 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study summary

The overall purpose of this global, multicenter, two cohort, central image evaluator masked study is to characterize the clinical safety and efficacy of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM) for the treatment of MacTel and to evaluate whether its safety profile and efficacy are comparable to those of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM).

Read the detailed description

This Phase 3 study consists of two cohorts:

  • Cohort 1 (Extension): Includes participants previously enrolled under the original protocol who received NT-501 (M-CHFM) and will continue follow-up. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason.
  • Cohort 2 (Expansion): Includes newly enrolled participants randomized 1:1 to receive either NT-501 (M-CHFM) or NT-501 (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.
02

Conditions studied

  • Macular Telangiectasia Type 2

Browse trials for

Keywords

  • Ciliary Neurotrophic Factor
  • Macular Telangiectasia (MacTel) Type 2
03

In context

Telangiectasis

69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.

This study's planned enrollment of 60 is above the median of 30 across 59 interventional studies indexed under Telangiectasis.

Browse Telangiectasis studies →

Lead sponsor

Neurotech Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.

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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Combination Product: M-CHFM

  • 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.

    Combination Product: M-CHFM

  • 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.

    Combination Product: CHFM

Interventions

  • Combination productM-CHFM

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

  • Combination productCHFM

    Single implantation of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM)

    Also known as: ENCELTO

06

What researchers measure

Primary outcomes

  1. Cohort 1 (Extension) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography

    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 of NT-501 in participants who received NT-501 with M-CHFM

    Time frame: Baseline to 24 months

  2. Cohort 2 (Expansion) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography

    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 of NT-501 in participants who received NT-501 with M-CHFM as compared to NT-501 with CHFM

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Cohort 1 (Extension) - Incidence of ocular and non-ocular adverse events

    Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline to 24 months

  2. Cohort 2 (Expansion) - Incidence of ocular and non-ocular adverse events

    Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline to 12 months

  3. Cohort 1 (Extension) - Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity

    Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart

    Time frame: Baseline to 24 months

  4. Cohort 2 (Expansion) - Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity

    Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart

    Time frame: Baseline to 12 months

Other outcomes

  1. Cohort 1 (Extension) - Aqueous CNTF Presence

    Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration

    Time frame: Month 12 - Month 24

  2. Cohort 2 (Expansion) - Aqueous CNTF Presence

    Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration

    Time frame: Baseline to 12 months

07

Study locations

1 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Mar 2025 (actual). Primary completion is estimated for May 2028, 37 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion May 2026 → May 2028 and completion Jul 2026 → Jul 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2024
First posted
May 2, 2024
StartActual
Mar 6, 2025
Primary completionEst.
May 1, 2028was May 2026
CompletionEst.
Jul 24, 2028was Jul 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Recruiting
changed Nov 3, 2026
Sites
3 sites added — first site in Australia. 6 sites changed recruiting status (3 now active, not recruiting, 2 now not yet recruiting, …)
Show 6 sites
  • Bay Area Retina Associates, A Medical Group · Walnut Creek, United Statesno status→Active, not recruiting
  • Foundation for Vision Research · Grand Rapids, United Statesno status→Active, not recruiting
  • Retina Consultants of Texas · Bellaire, United Statesno status→Active, not recruiting
  • Cerulea · East Melbourne, Australiano status→Not yet recruiting
  • Lion's Eye Institute · Perth, Australiano status→Recruiting
  • Sydney Eye Hospital · Sydney, Australiano status→Not yet recruiting
Show 3 added (3 Australia)
  • Cerulea · East Melbourne, Australia
  • Lion's Eye Institute · Perth, Australia
  • Sydney Eye Hospital · Sydney, Australia
across 2 updates, Oct 26, 2026 – Nov 3, 2026
Primary completion
May 1, 2026→May 1, 2028
Oct 26, 2026
Study completion
Jul 24, 2026→Jul 24, 2028
Oct 26, 2026
Enrollment
12 (actual)→60 (estimated)
Nov 3, 2026
Eligibility
2 inclusion criteria edited, 1 added; 2 exclusion criteria edited, 1 added; 2 criteria removed
What changed in the criteria
  • RemovedKey Eligibility Criteria:
  • RemovedKey Exclusion Criteria:
Inclusion criteria
  • AddedTo participate in this study, the potential subject and at least 1 of their eyes must meet all of the following criteria:
  • EditedSubjects 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.
  • EditedSubject must be greater than or equal to 21 years or olderof age and less than 80 years of age at screening.
Exclusion criteria
  • AddedTo 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):
  • EditedSubject 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.
  • ChangedBefore Previous participation in any Neurotech MacTel clinical trial unless the participant previously consented and screened for either the NTMT-03A or NTMT-03B study and were deemed a screen failure solely due to small lesion size.Now 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.
Nov 3, 2026
Interventions
Added Combination product: M-CHFM·Combination product: CHFM; removed Combination product: NT-501 CNTF Implant. Arms added: Cohort 1 (Extension) - M-CHFM·Cohort 2 (Expansion) - M-CHFM·Cohort 2 (Expansion) - CHFM; arms removed: NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM)
Nov 3, 2026
Primary outcomes
Revised in 2 updates
What changed on Nov 3, 2026
  • AddedCohort 1 (Extension) - EfficacyTime frame: Baseline to 24 months
  • AddedCohort 2 (Expansion) - EfficacyTime frame: Baseline to 12 months
  • RemovedRate of Change in Ellipsoid Zone (EZ) Area LossTime frame: Baseline through 12 months.
What changed on Nov 5, 2026
  • ChangedBefore Cohort 1 (Extension) - EfficacyNow Cohort 1 (Extension) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence TomographyTime frame: Baseline to 24 months
  • ChangedBefore Cohort 2 (Expansion) - EfficacyNow Cohort 2 (Expansion) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence TomographyTime frame: Baseline to 12 months
across 2 updates, Nov 3, 2026 – Nov 5, 2026
Secondary outcomes
Revised in 2 updates
What changed on Nov 3, 2026
  • AddedCohort 1 (Extension) - SafetyTime frame: Baseline to 24 months
  • AddedCohort 2 (Expansion) - SafetyTime frame: Baseline to 12 months
  • AddedCohort 1 (Extension) - Best Corrected Visual AcuityTime frame: Baseline to 24 months
  • AddedCohort 2 (Expansion) - Best Corrected Visual AcuityTime frame: Baseline to 12 months
  • RemovedSafety OutcomesTime frame: Baseline to 12 months
  • Addedother outcomeCohort 1 (Extension) - Aqueous CNTFTime frame: Month 12 - Month 24
  • Addedother outcomeCohort 2 (Expansion) - Aqueous CNTFTime frame: Baseline to 12 months
What changed on Nov 5, 2026
  • EditedCohort 1 (Extension) - SafetyIncidence of ocular and non-ocular adverse eventsTime frame: Baseline to 24 months
  • EditedCohort 2 (Expansion) - SafetyIncidence of ocular and non-ocular adverse eventsTime frame: Baseline to 12 months
  • EditedCohort 1 (Extension) - Best Corrected Visual AcuityPercentage of participants with a loss of 15 letters or more in best-corrected visual acuityTime frame: Baseline to 24 months
  • EditedCohort 2 (Expansion) - Best Corrected Visual AcuityPercentage of participants with a loss of 15 letters or more in best-corrected visual acuityTime frame: Baseline to 12 months
  • Editedother outcomeCohort 1 (Extension) - Aqueous CNTF PresenceTime frame: Month 12 - Month 24
  • Editedother outcomeCohort 2 (Expansion) - Aqueous CNTF PresenceTime frame: Baseline to 12 months
across 2 updates, Nov 3, 2026 – Nov 5, 2026
Contact
Study contact now listed: added p•••@neurotechusa.com · •••3880. See the current contact
Nov 3, 2026
Site contacts
Changed at 3 sites. See the sites
Show 3 sites
  • Cerulea · East Melbourne, AustraliaContact added t•••@ceruleaclinicaltrials.org.auContact added (no phone or email listed)
  • Lion's Eye Institute · Perth, AustraliaContact added d•••@lei.org.auContact added (no phone or email listed)
  • Sydney Eye Hospital · Sydney, AustraliaContact added e•••@sydney.edu.auContact added (no phone or email listed)
Nov 3, 2026
Title
A Study to Determine the Safety and Efficacy of NT-501 With MHFMM-CHFM
Nov 3, 2026
Show all 3 updates
  1. Nov 5, 2026
    Primary outcomes 2 edited
    What changed in the outcomes
    • ChangedBefore Cohort 1 (Extension) - EfficacyNow Cohort 1 (Extension) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence TomographyTime frame: Baseline to 24 months
    • ChangedBefore Cohort 2 (Expansion) - EfficacyNow Cohort 2 (Expansion) - Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence TomographyTime frame: Baseline to 12 months
    Secondary outcomes 6 edited
    What changed in the outcomes
    • EditedCohort 1 (Extension) - SafetyIncidence of ocular and non-ocular adverse eventsTime frame: Baseline to 24 months
    • EditedCohort 2 (Expansion) - SafetyIncidence of ocular and non-ocular adverse eventsTime frame: Baseline to 12 months
    • EditedCohort 1 (Extension) - Best Corrected Visual AcuityPercentage of participants with a loss of 15 letters or more in best-corrected visual acuityTime frame: Baseline to 24 months
    • EditedCohort 2 (Expansion) - Best Corrected Visual AcuityPercentage of participants with a loss of 15 letters or more in best-corrected visual acuityTime frame: Baseline to 12 months
    • Editedother outcomeCohort 1 (Extension) - Aqueous CNTF PresenceTime frame: Month 12 - Month 24
    • Editedother outcomeCohort 2 (Expansion) - Aqueous CNTF PresenceTime frame: Baseline to 12 months
    + 1 other change: verification date
  2. Nov 3, 2026
    Active, not recruiting→Recruiting
    6 sites changed recruiting status (3 now active, not recruiting, 2 now not yet recruiting, …)
    Show 6 sites
    • Bay Area Retina Associates, A Medical Group · Walnut Creek, United Statesno status→Active, not recruiting
    • Foundation for Vision Research · Grand Rapids, United Statesno status→Active, not recruiting
    • Retina Consultants of Texas · Bellaire, United Statesno status→Active, not recruiting
    • Cerulea · East Melbourne, Australiano status→Not yet recruiting
    • Lion's Eye Institute · Perth, Australiano status→Recruiting
    • Sydney Eye Hospital · Sydney, Australiano status→Not yet recruiting
    Enrollment 12 (actual)→60 (estimated)
    Eligibility 2 inclusion criteria edited, 1 added; 2 exclusion criteria edited, 1 added; 2 criteria removed
    What changed in the criteria
    • RemovedKey Eligibility Criteria:
    • RemovedKey Exclusion Criteria:
    Inclusion criteria
    • AddedTo participate in this study, the potential subject and at least 1 of their eyes must meet all of the following criteria:
    • EditedSubjects 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.
    • EditedSubject must be greater than or equal to 21 years or olderof age and less than 80 years of age at screening.
    Exclusion criteria
    • AddedTo 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):
    • EditedSubject 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.
    • ChangedBefore Previous participation in any Neurotech MacTel clinical trial unless the participant previously consented and screened for either the NTMT-03A or NTMT-03B study and were deemed a screen failure solely due to small lesion size.Now 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.
    Primary outcomes 2 added, 1 removed
    What changed in the outcomes
    • AddedCohort 1 (Extension) - EfficacyTime frame: Baseline to 24 months
    • AddedCohort 2 (Expansion) - EfficacyTime frame: Baseline to 12 months
    • RemovedRate of Change in Ellipsoid Zone (EZ) Area LossTime frame: Baseline through 12 months.
    Secondary outcomes 6 added, 1 removed
    What changed in the outcomes
    • AddedCohort 1 (Extension) - SafetyTime frame: Baseline to 24 months
    • AddedCohort 2 (Expansion) - SafetyTime frame: Baseline to 12 months
    • AddedCohort 1 (Extension) - Best Corrected Visual AcuityTime frame: Baseline to 24 months
    • AddedCohort 2 (Expansion) - Best Corrected Visual AcuityTime frame: Baseline to 12 months
    • RemovedSafety OutcomesTime frame: Baseline to 12 months
    • Addedother outcomeCohort 1 (Extension) - Aqueous CNTFTime frame: Month 12 - Month 24
    • Addedother outcomeCohort 2 (Expansion) - Aqueous CNTFTime frame: Baseline to 12 months
    Interventions Added Combination product: M-CHFM·Combination product: CHFM; removed Combination product: NT-501 CNTF Implant. Arms added: Cohort 1 (Extension) - M-CHFM·Cohort 2 (Expansion) - M-CHFM·Cohort 2 (Expansion) - CHFM; arms removed: NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM)
    Contact Study contact now listed: added p•••@neurotechusa.com · •••3880. See the current contact
    Site contacts Changed at 3 sites. See the sites
    Show 3 sites
    • Cerulea · East Melbourne, AustraliaContact added t•••@ceruleaclinicaltrials.org.auContact added (no phone or email listed)
    • Lion's Eye Institute · Perth, AustraliaContact added d•••@lei.org.auContact added (no phone or email listed)
    • Sydney Eye Hospital · Sydney, AustraliaContact added e•••@sydney.edu.auContact added (no phone or email listed)
    Title A Study to Determine the Safety and Efficacy of NT-501 With MHFMM-CHFM
    + 3 other changes: oversight details, description and design details
  3. Oct 26, 2026
    3 sites added — first site in Australia
    Show 3 added (3 Australia)
    • Cerulea · East Melbourne, Australia
    • Lion's Eye Institute · Perth, Australia
    • Sydney Eye Hospital · Sydney, Australia
    Primary completion May 1, 2026→May 1, 2028
    Study completion Jul 24, 2026→Jul 24, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06397131
Lead sponsor
Neurotech Pharmaceuticals
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Mar 6, 2025
Primary completion
May 1, 2028 (estimated)
Completion
Jul 24, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Patricia Davis
Contact
p.davis@neurotechusa.com
401-333-3880
Thomas Aaberg, Jr., MD
study chair · Neurotech Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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