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Macular Telangiectasia Type 2Phase 2NCT04729972

Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2

A Phase 2 study testing NT-501 CNTF implant in people with Macular Telangiectasia Type 2, run by Neurotech Pharmaceuticals at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Macular Telangiectasia Type 2
What is being tested?
NT-501 CNTF implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
10 sitesin 2 countries
Study dates
21 Jul 2021to 8 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria

  1. Participants from the NTMT-03 study must have completed the Month-24 visit
  2. Participant in the MacTel Phase 1/2 extension (NTMT-01/02E) study or the Phase 3 study must exit these studies prior to entering the Bilateral Implant safety study (NTMT-02B)
  3. Participant must be willing and able to follow the study instructions and be willing and able to complete all required study procedures and visits
  4. Participant must be willing and able to provide a signed Informed Consent, as well as written documentation in accordance with the relevant country and local privacy requirements, e.g., written data protection consent
  5. Females of childbearing potential must consent to a pregnancy test before entering the study
  6. A participant's refusal to allow the collection of blood samples for analysis of serum CNTF, serum Ab or Nab to CNTF, Ab to NTC-201.6A cells and Ab to DFHR levels in one eye will not exclude the participant from study participation

Ocular Inclusion Criteria

  1. Participant must have a positive diagnosis of MacTel type 2 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 in the study eye
  2. Participant must have steady fixation in the foveal or parafoveal area in the study eye and sufficiently clear media for good quality photographs

General Exclusion Criteria

  1. Females of childbearing potential (those who are not surgically sterilized or post- menopausal, i.e., absence of menstruation for 12 months or longer) may not participate in the study if any of the following conditions exists:
  • Pregnant (positive pregnancy test at Visit 1 or intend to become pregnant during the study)
  • Nursing (lactating)
  • Do not agree to use adequate birth control methods for the duration of the study and until 90 days after the last administration of study drug (adequate birth control methods are: hormonal - oral, implantable, transdermal or injectable contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm, intrauterine device [IUD] or surgical sterilization of partner, or total sexual abstinence)
  1. Participant is too ill to likely complete the entire study, based on the investigator's assessment
  2. Participant, in the opinion of the investigator, is not suitable for study participation
  3. Participant with any screening laboratory finding (serum chemistry, hematology, urinalysis) that in the opinion of the investigator is not suitable for study participation
  4. Participant has a history or current evidence of severe hypersensitivity to the NT-501 implant
  5. Participant has a history or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may in the opinion of the investigator preclude the safe administration of the NT-501 implant or adherence to the scheduled study visits, safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease; depression, cancer, or dementia

Ocular Exclusion Criteria

  1. Participant has a history or evidence of the following surgeries/procedures in the study eye, as assessed at Visit 1, including:
  • Submacular surgery
  • Vitrectomy
  • Retinal detachment
  • Incisional glaucoma surgery
  • Trabeculectomy or trabeculoplasty
  • Cataract surgery or laser-assisted in situ keratomileusis (LASIK) performed in the previous 6 months
  1. Participant has uncontrolled glaucoma; or ocular hypertension, i.e., IOP ≥ 25 mmHg in the study eye
  2. Participant has evidence of intraretinal or subretinal neovascularization or central serous chorioretinopathy in the study eye
  3. Participant has evidence of ocular disorder(s) in the study eye of a severity that could confound the interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period, including retinal vascular occlusion, severe nonproliferative or proliferative diabetic retinopathy, retinal detachment, macular hole, geographic atrophy, intraretinal or subretinal neovascularization, central serous chorio-retinopathy, pathological myopia
  4. Participant has a vitreous hemorrhage in the study eye at Visit 1 (Screening)
  5. Participant has a spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
  6. Participant has a history or evidence of penetrating ocular trauma in the study eye
  7. Participant has an anticipated need for cataract extraction in the study eye within 6 months of Visit 1 (Screening) such as 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
  8. Participant has uveitis, history of uveitis in either eye or history of ocular herpes virus in either eye
  9. Participant has undergone major surgery within the last 6 months (systemic or ocular in either eye) or who are likely to require major surgery within 6 months of Visit 1 (Screening)
  10. Participant has periocular or ocular/intraocular infection or inflammation in either eye (such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis) within 3 months prior to Visit 1 (Screening)
  11. Participant has ocular hypotension in either eye (<6 mmHg) that in the opinion of the Investigator would interfere with the NT-501 implant insertion
  12. Participant has a history of scleritis, scleral thinning, periocular, ocular, or intraocular infection or inflammation, cicatrizing conjunctival diseases any other ocular conditions in the study eye that could interfere with or complicate the surgery associated with NT-501implant insertion

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States7 sites
  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Massachusetts Eye and Ear Infirmary, Retina Service

    Boston, Massachusetts, 02114

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Jules Stein Eye Institute

    Los Angeles, California, 90095

  • Bascom Palmer

    Miami, Florida, 33136

  • National Eye Institute

    Washington D.C., District of Columbia, 20892

Other trials in United States

Australia3 sites
  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002

  • Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Save Sight Institute

    Sydney, New South Wales

Other trials in Australia

About this study

Official title: Phase II, Multicenter, Open-label Safety Study of Bilateral NT-501 in Participants With Macular Telangiectasia Type 2

This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.

Read the detailed description

This was a multicenter, open-label study designed to evaluate the safety of bilateral NT-501 in subjects with MacTel. All subjects who received NT-501 in a single eye prior to or in the Phase 1/2 extension study (NTMT-01/02E) or in 1 of the 2 Phase 3 studies (NTMT-03-A or NTMT-03-B), and met all other eligibility criteria, qualified for participation in the current study; enrolled subjects underwent intraocular implantation of NT-501 in the fellow eye and were followed for 6 months. Note that, throughout this report, all references to "study eye" mean the eye that received NT-501 in the current study (ie, not the eye that was treated in the previous study).

Being tested
NT-501 CNTF implant
Keywords
Macular Telangiectasia Type 2, CNTF, Mactel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NT-501 CNTF implantCombination product

    Single implantation of CNTF-secreting NT-501 device into fellow (untreated) eye

Study groups in NCT04729972
Study groupRoleWhat they receive
NT-501 in Fellow EyeExperimentalNT-501 was implanted on Day 0 in the fellow eye of subjects who received a single NT-501 in a previous study; subjects were followed for 6 months post-implantation of NT-501 in this study.
Receives: Combination Product: NT-501 CNTF implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Ocular and/or Non-ocular Treatment Emergent Adverse Events

    Assess the incidence and severity of adverse events (AEs) following bilateral ocular implantation of NT-501

    Measured: 6 months

Secondary outcomes (1)
  1. Serum Levels of CNTF and Immunogenicity for NT-501

    Incidence of positive serum levels of CNTF and immunogenicity for NT-501 with quantification of antibodies (Ab) to CNTF, neutralizing antibodies (NAb) to CNTF, Ab to NTC-201-6A cells, and Ab to mouse dihydrofolate reductase (mDHFR) at any time.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start21 Jul 2021
  3. Primary completion8 Dec 2022
  4. Study completion8 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04729972
Sponsor's protocol ID
NTMT-02B
Status last verified
Mar 2025
First submitted
25 Jan 2021
Last updated
26 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Chew EY, Clemons TE, Jaffe GJ, Johnson CA, Farsiu S, Lad EM, Guymer R, Rosenfeld P, Hubschman JP, Constable I, Wiley H, Singerman LJ, Gillies M, Comer G, Blodi B, Eliott D, Yan J, Bird A, Friedlander M; Macular Telangiectasia Type 2-Phase 2 CNTF Research Group. Effect of Ciliary Neurotrophic Factor on Retinal Neurodegeneration in Patients with Macular Telangiectasia Type 2: A Randomized Clinical Trial. Ophthalmology. 2019 Apr;126(4):540-549. doi: 10.1016/j.ophtha.2018.09.041. Epub 2018 Oct 4.

    PubMed 30292541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NT-501 CNTF implant in people with Macular Telangiectasia Type 2, run by Neurotech Pharmaceuticals at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Ocular and/or Non-ocular Treatment Emergent Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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