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Open label, single-treatment, with a concurrent non-treatment control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 DWEK/DSO | No Intervention | Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114 | |
| Group 2 TTHX1114 in combination with DWEK/DSO | Experimental | Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO |
|
| Group 3 TTHX1114 in combination with DWEK/DSO | Experimental | Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO |
|
| Group 1a | Experimental | Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections) |
|
| Group 3a | Experimental | Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTHX1114(NM141) | Drug | TTHX1114 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Change from baseline | Day 28 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Tremblay | Trefoil Therapeutics.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trefoil Investigational Site 124 | Long Beach | California | 90805 | United States | ||
| North Bay Eye Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39509248 | Derived | Moloney G, Al-Zanki S, Burgos-Blasco B, Fadaifard Martinez M, Bujak M, Dhaliwal DK. Severe Corneal Flattening After Endothelial Keratoplasty: Collagen Compaction Syndrome. Cornea. 2024 Nov 7;44(5):653-658. doi: 10.1097/ICO.0000000000003752. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2023 | Dec 27, 2023 | 9 | ||
| Sep 27, 2024 |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| Petaluma |
| California |
| 94954 |
| United States |
| Trefoil Investigational Site 123 | Deerfield Beach | Florida | 33064 | United States |
| Trefoil Investigational Site 119 | Fort Myers | Florida | 33907 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Vance Thompson Vision - Bozeman | Bozeman | Montana | 59718 | United States |
| Vance Thompson Vision - Omaha | Omaha | Nebraska | 68137 | United States |
| Vance Thompson Vision - Fargo | West Fargo | North Dakota | 58078 | United States |
| Trefoil Investigational Site 120 | Cincinnati | Ohio | 45242 | United States |
| Vance Thompson Vision - Sioux Falls | Sioux Falls | South Dakota | 57108 | United States |
| Oct 21, 2024 |
| 10 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |