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

NCT06397131 | Active Not Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: NTMT-03C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Macular Telangiectasia Type 2

Keywords

Ciliary Neurotrophic Factor; Macular Telangiectasia (MacTel) Type 2

Outcome Measures

Primary Outcomes (1)

• Rate of Change in Ellipsoid Zone (EZ) Area Loss

  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.

  Baseline through 12 months.

Secondary Outcomes (1)

• Safety Outcomes

  Baseline to 12 months

Study Arms (1)

NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM)

EXPERIMENTAL

Participants to receive CNTF implant in one eye using MHFM.

Combination Product: NT-501 CNTF Implant

Interventions

NT-501 CNTF Implant COMBINATION_PRODUCT

Single implantation of CNTF-secreting NT-501 hCNTF device into one eye.

NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject is medically unable to comply with study procedures or follow-up visits.
• Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
• 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.
• 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).
• Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
• Subject has evidence of intraretinal hyperreflectivity by OCT.
• Subject has evidence of central serous chorio-retinopathy in either eye.
• Subject has evidence of pathologic myopia in either eye.
• Subject has significant corneal or media opacities in either eye.
• Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
• 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.
• Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
• 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.
• 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.
• Subject is on chemotherapy.

Sponsors & Collaborators

• Neurotech Pharmaceuticals: lead

Study Sites (3)

Bay Area Retina Associates, A Medical Group

Walnut Creek, California, 94598, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Study Officials

• Thomas Aaberg, Jr., MD

  Neurotech Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: March 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)