Full metadata record
DC Field | Value | Language |
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dc.contributor.author | Yoo, Seunghoon | - |
dc.contributor.author | You, Dae Hyuk | - |
dc.contributor.author | Lee, Jeongyoon | - |
dc.contributor.author | Hong, H. Christian | - |
dc.contributor.author | Lee, Sung Jin | - |
dc.date.accessioned | 2023-07-23T17:10:17Z | - |
dc.date.available | 2023-07-23T17:10:17Z | - |
dc.date.created | 2023-02-09 | - |
dc.date.issued | 2023-01 | - |
dc.identifier.issn | 1010-660X | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11750/46219 | - |
dc.description.abstract | Background and objectives: EG-Mirotin (active ingredient EGT022) targets nonproliferative diabetic retinopathy (NPDR), the early stage of retinopathy. EG-Mirotin reverses capillary damage before NPDR progresses to an irreversible stage. EG-Mirotin safety and efficacy were investigated in patients with type 1 or type 2 diabetes mellitus and moderate to severe NPDR. Methods: In this open-label, single-arm, single-center, exploratory phase II study, 10 patients (20 eyes) received EG-Mirotin once a day (3 mg/1.5 mL sterile saline) for 5 days and were evaluated for ischemic index changes and safety. End of study was approximately 8 ± 1 weeks (57 ± 7 days) after the first drug administration. Results: EG-Mirotin injections were well tolerated, with no dose-limiting adverse events, serious adverse events, or deaths. Four treatment-emergent adverse events (TEAEs) unrelated to the investigational drug were observed in 2 out of 10 participants (20%) who had received the investigational drug. The overall average percent change in ischemic index at each evaluation point compared with baseline was statistically significant (Greenhouse–Geisser F = 9.456, p = 0.004 for the main effect of time), and a larger change was observed when the baseline ischemic index value was high (Greenhouse–Geisser F = 10.946, p = 0.002 for time × group interaction). Conclusions: The EG-Mirotin regimen established in this study was shown to be feasible and safe and was associated with a trend toward potential improvement in diabetes-induced ischemia and retinal capillary leakage. © 2023 by the authors. | - |
dc.language | English | - |
dc.publisher | MDPI | - |
dc.title | A Nonrandomized Phase 2 Trial of EG-Mirotin, a Novel, First-in-Class, Subcutaneously Deliverable Peptide Drug for Nonproliferative Diabetic Retinopathy | - |
dc.type | Article | - |
dc.identifier.doi | 10.3390/medicina59010178 | - |
dc.identifier.scopusid | 2-s2.0-85147045427 | - |
dc.identifier.bibliographicCitation | Medicina, v.59, no.1 | - |
dc.description.isOpenAccess | TRUE | - |
dc.subject.keywordAuthor | diabetic retinopathy | - |
dc.subject.keywordAuthor | nonproliferative diabetic retinopathy | - |
dc.subject.keywordAuthor | retinal ischemia | - |
dc.subject.keywordPlus | MACULAR EDEMA | - |
dc.subject.keywordPlus | ANTI-VEGF | - |
dc.subject.keywordPlus | COMPLICATIONS | - |
dc.subject.keywordPlus | MECHANISMS | - |
dc.subject.keywordPlus | PERICYTES | - |
dc.subject.keywordPlus | AGENTS | - |
dc.citation.number | 1 | - |
dc.citation.title | Medicina | - |
dc.citation.volume | 59 | - |
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