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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-501 CNTF Implant with Medica Hollow Fiber Membrane (MHFM) | Experimental | Participants to receive CNTF implant in one eye using MHFM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-501 CNTF Implant | Combination Product | Single implantation of CNTF-secreting NT-501 hCNTF device into one eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes | The number and severity of adverse events post-implantation. | Baseline to 12 months |
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Key Eligibility Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Aaberg, Jr., MD | Neurotech Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Area Retina Associates, A Medical Group | Walnut Creek | California | 94598 | United States | ||
| Foundation for Vision Research |
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| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |