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Eye implant for rare vision loss gets Long-Term safety review

NCT ID NCT06971939

Disease control Sponsor: Neurotech Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of an eye implant (NT-501) for people with MacTel type 2, a rare disease that damages the center of the retina. About 285 adults who already received the implant in earlier studies will be followed, and some who had a sham procedure can now get the real implant. The main goal is to track side effects and vision changes over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria To be eligible to participate in this study, an individual participant must meet all the following criteria: 1. Male or female adult participants who previously completed an NT-501 MacTel clinical study and: 1. Arm 1: received NT-501 intraocular implant in either Phase 3 study (NTMT-03-A or NTMT-03-B) and have retained at least 1 NT-501 at study entry. 2. Arm 2: received NT-501 intraocular implant in the Phase 1 study (NTMT-01), Phase 2 study (NTMT-02), or in the substudy of the Phase 1 and Phase 2 extension study (NTMT-01/02E) and have retained at least 1 NT-501 at study entry. Note: participants who received NT-501 in both eyes (ie, participated in study NTMT-02B) will be enrolled in either Arm 1 or Arm 2 based on the study in which the first NT 501 was implanted (ie, participants who received the first implant in a Phase 3 study will be enrolled in Arm 1 and those who received the first implant in the Phase 1 study or Phase 2 study will be enrolled in Arm 2). 3. Arm 3: underwent the sham procedure in either Phase 3 study (NTMT-03-A or NTMT-03-B) 2. Participant 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 (ICH) Good Clinical Practice (GCP) guidelines, and local regulations, before initiating any clinical study related procedures. 3. Arm 3: female participants of childbearing potential must agree to use highly effective contraception. Highly effective forms of contraception (generally a first-year typical use pregnancy risk of 1% or less) include the following: contraceptive implants; an intrauterine device; permanent contraceptive procedures (vasectomy, bilateral salpingectomy, bilateral tubal occlusion, or partial salpingectomy); abstinence. A combination of male condom with either cap, diaphragm, or sponge with spermicide (ie, double barrier methods) is also considered an acceptable, but not highly effective, method of birth control. Exclusion Criteria To participate in this study, the potential participant must not meet any of the following criteria. (Note that the ocular exclusion criteria are relevant to the study eye\[s\], unless indicated for both eyes): Exclusion Criteria Applicable to Arms 1, 2, and 3: 1. Participant is medically unable to comply with clinical study procedures or visits. 2. Participant 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. 3. Participant has undergone explantation of NT-501 prior to screening. Note: A participant who received bilateral implants and underwent explantation in only 1 eye prior to screening may be enrolled in the study. 4. Participant received Encelto commercial implant in the fellow eye, if applicable, less than 3 months prior to study screening. Exclusion Criteria Applicable to Arm 3 Only: 5. Participant has significant corneal or media opacities in the study eye to be implanted. 6. Participant has evidence of pathologic myopia in the study eye to be implanted. 7. Participant has any of the following lens opacities in the study eye to be implanted: 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. Note: the participant can be reconsidered for enrollment 90 days after undergoing cataract surgery. 8. Participant has undergone lens removal in the study eye to be implanted in the previous 3 months or YAG laser within 4 weeks of the screening/baseline visit. 9. Participant has evidence of ocular disease in the study eye to be implanted other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (eg. glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis). 10. Received intravitreal steroid therapy in the study eye to be implanted within 6 months prior to screening. 11. Evidence of active exudative intraretinal neovascularization or subretinal neovascularization in the study eye to be implanted, as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid. 12. Evidence of central serous chorioretinopathy in the study eye to be implanted within 3 months prior to screening. 13. A history of ocular herpes virus in the study eye to be implanted. 14. Participant is on chemotherapy. 15. Participant is pregnant or breastfeeding. 16. Participation in any other clinical study of an intervention (drug or device) within 6 months prior to the screening/baseline visit. 17. A history of malignancy that would compromise survival during the clinical study.

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Conditions

The condition(s) this trial relates to.

macular telangiectasia type 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Macular telangiectasia type 2 (mactel)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bascom Palmer

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • Bay Area Retina Associates

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Cerulea

    RECRUITING

    East Melbourne, Australia

  • Cincinnati Eye Institute

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Colorado Retina

    NOT_YET_RECRUITING

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina Consultants

    NOT_YET_RECRUITING

    Frederick, Maryland, 21702, United States

  • Emory Eye Center

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Envision Ocular, LLC

    NOT_YET_RECRUITING

    Bloomfield, New Jersey, 07003, United States

  • Foundation for Vision Research

    RECRUITING

    Grand Rapids, Michigan, 49525, United States

  • Jules Stein Eye Institute/UCLA

    NOT_YET_RECRUITING

    Los Angeles, California, 90085, United States

  • Lion's Eye Institute

    RECRUITING

    Perth, Australia

  • Massachusetts Eye and Ear Infirmary, Retina Service

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • National Eye Institute

    NOT_YET_RECRUITING

    Bethesda, Maryland, 20892, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Retina Associates of Cleveland, Inc.

    RECRUITING

    Cleveland, Ohio, 44126, United States

  • Retina Center of Texas

    RECRUITING

    Dallas, Texas, 75251, United States

  • Retina Consultants of Minnesota

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55435, United States

  • Retina Consultants of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Retina Northwest, P.C.

    NOT_YET_RECRUITING

    Portland, Oregon, 97221, United States

  • Scheie Eye Institute

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Scripps Health

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • Southeastern Retina Associates, P.C.

    RECRUITING

    Knoxville, Tennessee, 37922, United States

  • Stanford University School of Medicine

    NOT_YET_RECRUITING

    Palo Alto, California, 94303, United States

  • Sydney Eye Hospital

    RECRUITING

    Sydney, Australia

  • Texas Retina Associates

    RECRUITING

    Dallas, Texas, 75231, United States

  • University of Utah John A. Moran Center

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84132, United States

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