NT-501 Implant for Macular Telangiectasia

Recruiting at 2 trial locations

Overseen By Patty Davis

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neurotech Pharmaceuticals

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to determine the long-term levels of CNTF, and the clinical safety and efficacy of the NT-501 implants with the Medica Hollow Fiber Membrane (MHFM) in participants with macular telangiectasia type 2.

Research Team

Thomas Aaberg, Jr., MD

Principal Investigator

Neurotech Pharmaceuticals

Eligibility Criteria

This trial is for individuals with a condition affecting the blood vessels in their eyes, known as macular telangiectasia type 2. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or severity of the condition.

Inclusion Criteria

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

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.

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.

Exclusion Criteria

I have been diagnosed with a specific eye condition affecting my retina.

I am currently undergoing chemotherapy.

Subject with a history of ocular herpes virus in either eye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NT-501 CNTF implant in one eye using the Medica Hollow Fiber Membrane (MHFM)

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NT-501

Trial Overview The study is testing NT-501 implants which release CNTF (a protein that could help eye cells) using MHFM technology. It aims to see if this can safely improve vision or slow vision loss over time in those with macular telangiectasia type 2.

Participant Groups

Group I: NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM) Experimental Treatment 1 Intervention

Participants to receive CNTF implant in one eye using MHFM.

NT-501 is already approved in United States for the following indications:

Approved in United States as NT-501 for:

• Glaucoma
• Retinitis pigmentosa
• Age-related macular degeneration

Who Is Running the Clinical Trial?

Neurotech Pharmaceuticals

Lead Sponsor

Trials

12

Recruited

680+