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| Name | Class |
|---|---|
| The Lowy Medical Research Institute Limited | OTHER |
| The Emmes Company, LLC | INDUSTRY |
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This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-501 Implant procedure | Experimental | The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF). |
|
| Sham procedure | Sham Comparator | Non-penetrating sham procedure to mimic implant procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciliary neurotrophic factor (CNTF) | Biological | Ciliary neurotrophic factor released from NT-501 encapsulated cell implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s) | Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ellipsoid zone | Change in the ellipsoid zone from baseline to Month 12. | 12 months |
| Retinal sensitivity (dB) as measured by microperimetry | Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Cone density as measured by AOSLO | Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants. | 12 and 24 Months |
| National Eye Institute Visual Functioning Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States | ||
| Bascom Palmer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33229343 | Derived | Loo J, Cai CX, Choong J, Chew EY, Friedlander M, Jaffe GJ, Farsiu S. Deep learning-based classification and segmentation of retinal cavitations on optical coherence tomography images of macular telangiectasia type 2. Br J Ophthalmol. 2022 Mar;106(3):396-402. doi: 10.1136/bjophthalmol-2020-317131. Epub 2020 Nov 23. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2025 | |
| Reset | May 1, 2025 |
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| Sham procedure | Procedure | Sham surgery for Sham arm |
|
| NT-501 Implant | Device | NT-501 encapsulated cell implant |
|
| NT-501 Implant procedure | Procedure | Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm |
|
| 12 and 24 months |
| Increase in ellipsoid zone | Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24. | 12 and 24 months |
| Visual Acuity | Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24. | 12 and 24 months |
| Visual Acuity | Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24. | 12 and 24 Months |
| Visual Acuity | Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24. | 12 and 24 Months |
| Reading Speed | Change in reading speed as measured by the IReST from baseline to Months 12 and 24. | 12 and 24 Months |
Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24.
| 12 and 24 months |
| Electroretinogram changes | Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants. | 6, 12 and 24 Months |
| Miami |
| Florida |
| 33136 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| National Eye Institute | Bethesda | Maryland | 20892 | United States |
| Massachusetts Eye and Ear Infirmary, Retina Service | Boston | Massachusetts | 02114 | United States |
| University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Retina Associates of Cleveland, Inc. | Beachwood | Ohio | 44122 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Save Sight Institute | Sydney | New South Wales | Australia |
| Centre for Eye Research Australia | East Melbourne | Australia |
| Lions Eye Institute | Nedlands | Australia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2025 | May 1, 2025 |
| ID | Term |
|---|---|
| D020934 | Ciliary Neurotrophic Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |
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