|
|
|
|
| LEADER |
01000caa a22002652c 4500 |
| 001 |
NLM34754715X |
| 003 |
DE-627 |
| 005 |
20250303232638.0 |
| 007 |
cr uuu---uuuuu |
| 008 |
231226s2022 xx |||||o 00| ||eng c |
| 024 |
7 |
|
|a 10.3928/23258160-20220923-02
|2 doi
|
| 028 |
5 |
2 |
|a pubmed25n1158.xml
|
| 035 |
|
|
|a (DE-627)NLM34754715X
|
| 035 |
|
|
|a (NLM)36239675
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 100 |
1 |
|
|a Boyer, David S
|e verfasserin
|4 aut
|
| 245 |
1 |
4 |
|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
|
| 264 |
|
1 |
|c 2022
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a ƒaComputermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a ƒa Online-Ressource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a Date Completed 20.10.2022
|
| 500 |
|
|
|a Date Revised 15.11.2022
|
| 500 |
|
|
|a published: Print-Electronic
|
| 500 |
|
|
|a Citation Status MEDLINE
|
| 520 |
|
|
|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)
|
| 520 |
|
|
|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
|
| 520 |
|
|
|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
|
| 520 |
|
|
|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>
|
| 650 |
|
4 |
|a Clinical Trial, Phase I
|
| 650 |
|
4 |
|a Journal Article
|
| 650 |
|
4 |
|a Multicenter Study
|
| 650 |
|
4 |
|a Randomized Controlled Trial
|
| 650 |
|
4 |
|a Research Support, Non-U.S. Gov't
|
| 650 |
|
7 |
|a Integrins
|2 NLM
|
| 650 |
|
7 |
|a Ophthalmic Solutions
|2 NLM
|
| 700 |
1 |
|
|a Kaiser, Peter K
|e verfasserin
|4 aut
|
| 700 |
1 |
|
|a Magrath, George N
|e verfasserin
|4 aut
|
| 700 |
1 |
|
|a Brady, Kerrie
|e verfasserin
|4 aut
|
| 700 |
1 |
|
|a Edwards, Scott
|e verfasserin
|4 aut
|
| 700 |
1 |
|
|a Tanzer, David J
|e verfasserin
|4 aut
|
| 700 |
1 |
|
|a Heier, Jeffrey S
|e verfasserin
|4 aut
|
| 773 |
0 |
8 |
|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
|
| 773 |
1 |
8 |
|g volume:53
|g year:2022
|g number:10
|g day:17
|g month:10
|g pages:553-560
|
| 856 |
4 |
0 |
|u http://dx.doi.org/10.3928/23258160-20220923-02
|3 Volltext
|
| 912 |
|
|
|a GBV_USEFLAG_A
|
| 912 |
|
|
|a SYSFLAG_A
|
| 912 |
|
|
|a GBV_NLM
|
| 912 |
|
|
|a GBV_ILN_24
|
| 912 |
|
|
|a GBV_ILN_31
|
| 912 |
|
|
|a GBV_ILN_40
|
| 912 |
|
|
|a GBV_ILN_63
|
| 912 |
|
|
|a GBV_ILN_65
|
| 912 |
|
|
|a GBV_ILN_69
|
| 912 |
|
|
|a GBV_ILN_70
|
| 912 |
|
|
|a GBV_ILN_90
|
| 912 |
|
|
|a GBV_ILN_91
|
| 912 |
|
|
|a GBV_ILN_130
|
| 912 |
|
|
|a GBV_ILN_135
|
| 912 |
|
|
|a GBV_ILN_136
|
| 912 |
|
|
|a GBV_ILN_151
|
| 912 |
|
|
|a GBV_ILN_181
|
| 912 |
|
|
|a GBV_ILN_203
|
| 912 |
|
|
|a GBV_ILN_217
|
| 912 |
|
|
|a GBV_ILN_235
|
| 912 |
|
|
|a GBV_ILN_289
|
| 912 |
|
|
|a GBV_ILN_294
|
| 912 |
|
|
|a GBV_ILN_297
|
| 912 |
|
|
|a GBV_ILN_350
|
| 912 |
|
|
|a GBV_ILN_352
|
| 912 |
|
|
|a GBV_ILN_674
|
| 912 |
|
|
|a GBV_ILN_676
|
| 912 |
|
|
|a GBV_ILN_688
|
| 912 |
|
|
|a GBV_ILN_698
|
| 912 |
|
|
|a GBV_ILN_721
|
| 912 |
|
|
|a GBV_ILN_737
|
| 912 |
|
|
|a GBV_ILN_791
|
| 912 |
|
|
|a GBV_ILN_812
|
| 951 |
|
|
|a AR
|
| 952 |
|
|
|d 53
|j 2022
|e 10
|b 17
|c 10
|h 553-560
|