NT-501 for MacTel

Recruiting at 18 trial locations

Overseen By Patricia Davis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Neurotech Pharmaceuticals

Must not be taking: Intravitreal steroids, Anti-VEGF

Disqualifiers: Ocular disease, Chemotherapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

285 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.

Research Team

Thomas Aaberg, Jr, MD

Principal Investigator

Neurotech Pharmaceuticals

Eligibility Criteria

This trial is for people with a condition called MacTel Type 2 who have already been part of earlier phases (1, 2, or 3) of NT-501 studies. It's also open to those who had a sham procedure in Phase 3 and now choose to get the real NT-501 implant.

Inclusion Criteria

I have completed an NT-501 MacTel study before.

I can focus steadily and have clear enough vision for quality retinal images.

I can give my consent or have someone who can legally do it for me.

Exclusion Criteria

Participant is living outside the US

I have a history of cancer.

I haven't had cancer in the last 5 years, except for skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants in Arm 3 who previously underwent the sham procedure will receive the NT-501 implant

Perioperative period

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety and efficacy of NT-501 implant

5 years

Annual visits (in-person)

Treatment Details

Interventions

• NT-501

Trial Overview The study tests the long-term safety and effectiveness of an eye implant called NT-501 for treating MacTel Type 2. Participants from previous trials will continue to be observed, and new participants from the sham group will receive the actual treatment.

Participant Groups

Group I: Arm 3 (Phase 3 Sham to Implant Crossover) Experimental Treatment 1 Intervention

For participants who underwent Sham procedure in either Phase 3 study (NTMT-03-A or NTMT-03-B) and will receive NT-501 in this study.

Group II: Arm 2 (Phase 1 and Phase 2 Long-term Follow-up) Experimental Treatment 1 Intervention

For participants who received NT-501 (ENCELTO) in a previous Phase 1 study (NTMT-01), Phase 2 study (NTMT-02), in the sub study of Phase 1 and Phase 2 extension study (NTMT-01/02E), or for participants who received NT-501 (ENCELTO) in both eyes (i.e. participated in study NTMT-02B) but received the first NT-501 (ENCELTO) implant in a Phase 1 or Phase 2 study. No new treatment intervention will be administered. Arm 2 is focused on long term follow-up for participant who already has the ENCELTO implant at time of study screening and enrollment.

Group III: Arm 1 (Phase 3 Long-term Follow-up) Experimental Treatment 1 Intervention

For participants who received NT-501 (ENCELTO) in a previous Phase 3 study (NTMT-03-A or NTMT-03-B), or for participants who received NT-501 (ENCELTO) in both eyes (i.e. participated in study NTMT-02B) but received the first NT-501 (ENCELTO) implant in a Phase 3 study. No new treatment intervention will be administered. Arm 2 is focused on long term follow-up for participant who already has the ENCELTO implant at time of study screening and enrollment.

Who Is Running the Clinical Trial?

Neurotech Pharmaceuticals

Lead Sponsor

Trials

12

Recruited

680+