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

Phase 3

Not yet recruiting

• Conditions: Macular Telangiectasia Type 2
• Interventions: Combination Product: NT-501 CNTF Implant

• Registration Number: NCT06397131
• Lead Sponsor: Neurotech Pharmaceuticals

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.

Detailed Description

Two parallel randomized, controlled Phase 3 clinical trials showed that placing an NT-501 in the eyes of subjects with macular telangiectasia type 2 (MacTel) provides vision benefit with an acceptable risk profile. The NT-501 device used in these Phase 3 trials has a hollow fiber membrane (HFM) which houses the CNTF producing engineered NTC-201-6A cells. The produced CNTF passes through the membrane into the vitreous cavity of the affected eye and similarly required cell nutrients pass from the vitreous cavity through the membrane to the NTC-201-6A cells. NT-501 used in the above mentioned Phase 3 studies was manufactured with the clinical HFM (referred to as CHFM) from a single sourced supplier. Another supplier of this critical HFM component of the NT-501 has been identified. This membrane will be referred to as the Medica Hollow Fiber Membrane (MHFM). Though the NT-501 product manufactured with the MHFM has the same configuration, same RPE cells, and produces CNTF levels similar to the original NT-501 product manufactured with clinical membrane (CHFM) when tested in vivo (animal model), it has not been tested in humans. The purpose of this study is to characterize the clinical safety and efficacy of NT-501 with MHFM, consistent with the clinical safety and efficacy of NT-501 with CHFM.

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Study Start: 2025-04-01
• Primary Completion: 2026-04-27
• Study Completion: 2026-07-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Subject is medically unable to comply with study procedures or follow-up visits.
2. Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
3. 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.
4. 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).
5. Subject has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome. The exceptions to this exclusion criteria include artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
6. Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
7. Subject has evidence of intraretinal hyperreflectivity by OCT.
8. Subject has evidence of central serous chorio-retinopathy in either eye.
9. Subject has evidence of pathologic myopia in either eye.
10. Subject has significant corneal or media opacities in either eye.
11. Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
12. 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.
13. Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
14. 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.
15. Subject is on chemotherapy.
16. Subject is pregnant or breastfeeding.
17. Subject has a history of malignancy that would compromise the 12-month study survival.
18. Subject with a history of ocular herpes virus in either eye.
19. Subject 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.
20. Subject has evidence of subfoveal RPE hyperplasia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM)	NT-501 CNTF Implant	Participants to receive CNTF implant in one eye using MHFM.

Primary Outcome Measures

Name	Time	Method
Rate of Change in Ellipsoid Zone (EZ) Area Loss	Baseline through 12 months.	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.

Secondary Outcome Measures

Name	Time	Method
Safety Outcomes	Baseline to 12 months	The number and severity of adverse events post-implantation.

Trial Locations

Locations (3)

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

Bay Area Retina Associates, A Medical Group; 🇺🇸 Walnut Creek, California, United States

Foundation for Vision Research; 🇺🇸 Grand Rapids, Michigan, United States