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231226s2022 xx |||||o 00| ||eng c |
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|a 10.3928/23258160-20220923-02
|2 doi
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|a pubmed25n1158.xml
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|a (NLM)36239675
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|a DE-627
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|e rakwb
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|a eng
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| 100 |
1 |
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|a Boyer, David S
|e verfasserin
|4 aut
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|a The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease
|b A Phase 1b Study
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|c 2022
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|a Text
|b txt
|2 rdacontent
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|a ƒaComputermedien
|b c
|2 rdamedia
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|a ƒa Online-Ressource
|b cr
|2 rdacarrier
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|a Date Completed 20.10.2022
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|a Date Revised 15.11.2022
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|a published: Print-Electronic
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|a Citation Status MEDLINE
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|a BACKGROUND AND OBJECTIVES: To evaluate the safety, tolerability, and biological activity of a topical selective integrin inhibitor (OTT166) eyedrop administered BID for diabetic retinopathy (DR) and diabetic macular edema (DME)
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|a STUDY DESIGN/MATERIALS AND METHODS: A prospective, multicenter, randomized, double-masked Phase 1b study. Subjects with nonproliferative DR and DME with central subfield thickness (CST) > 325 microns were randomized to OTT166 eyedrops (2.5% or 5%) BID for 28 days. Subjects were followed for an additional 28 days after treatment cessation
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|a RESULTS: Forty-four subjects were enrolled. No drug-related serious adverse events (SAEs) and two drug-related adverse events (AEs) were reported. OTT166 was well-tolerated with no evidence of ocular toxicity. Best-corrected visual acuity (BCVA) remained stable. Mean central retinal thickness (CRT) overall was variable: +12.8/+1.8 microns at Day 28 (end of treatment) and -50.3/+5.5 microns at Day 56 (end of study) for the 2.5% and 5% groups, respectively. Median CRT overall demonstrated consistent reduction by end of study: -39.0/-16.5 microns for the 2.5% and 5% groups, respectively. Median responses were greater in the treatment-naïve group (-41.5/-26.0 microns for the 2.5% and 5% groups, respectively). Thirty-seven percent of 'responder' subjects exhibited a mean reduction in CRT of 46.6 microns on optical coherence tomography (OCT) at end of treatment (Day 28) which persisted to end of the study (Day 56) - mean reduction of 67.4 microns, suggesting a durable effect
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|a CONCLUSION: OTT166 eyedrops were safe, well-tolerated, and demonstrated biological activity in 37% of responders. These results warrant further evaluation of OTT166 eyedrops. <b>[<i>Ophthalmic Surg Lasers Imaging Retina</i> 2022;53:553-560.]</b>
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|a Clinical Trial, Phase I
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|a Journal Article
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|a Multicenter Study
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|a Randomized Controlled Trial
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|a Research Support, Non-U.S. Gov't
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|a Integrins
|2 NLM
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| 650 |
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|a Ophthalmic Solutions
|2 NLM
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1 |
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|a Kaiser, Peter K
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Magrath, George N
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Brady, Kerrie
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Edwards, Scott
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Tanzer, David J
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Heier, Jeffrey S
|e verfasserin
|4 aut
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| 773 |
0 |
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|i Enthalten in
|t Ophthalmic surgery, lasers & imaging retina
|d 2013
|g 53(2022), 10 vom: 17. Okt., Seite 553-560
|w (DE-627)NLM224956647
|x 2325-8179
|7 nnas
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| 773 |
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|g volume:53
|g year:2022
|g number:10
|g day:17
|g month:10
|g pages:553-560
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|u http://dx.doi.org/10.3928/23258160-20220923-02
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