Matches in SemOpenAlex for { <https://semopenalex.org/work/W2913565900> ?p ?o ?g. }
- W2913565900 endingPage "1960" @default.
- W2913565900 startingPage "1960" @default.
- W2913565900 abstract "Purpose : Currently, there is only one predominant treatment paradigm for diabetic macular edema (DME): anti-VEGF agent as first line, followed by corticosteroids as second line. We performed a double-masked, placebo-controlled, randomized multi-center phase 2b trial to evaluate the safety & efficacy of ALG-1001, a novel first-in-class integrin inhibitor, as compared to bevacizumab in DME.Methods : 80 subjects were randomly assigned to 5 treatment groups: 1.25mg bevacizumab control arm of 5 monthly injections (Group 1); single treatment of 1.25mg bevacizumab at week 0 followed by three ALG-1001 injections (1.0mg or 0.5mg) at weeks 1, 4 and 8 (Groups 2 & 3); ALG-1001 (1.0mg or 0.5mg) given in direct combination with bevacizumab 1.25mg at weeks 1, 4 and 8 (Groups 4 & 5). Efficacy outcomes were change from baseline in BCVA and OCT CMT at week 20.Results : 65 subjects were included in the per protocol population. Group 2 demonstrated the best efficacy among the ALG-1001 groups. Mean change in BCVA were 6.7 and 7.1 letters for 1.25mg bevacizumab and ALG-1001 1.0mg in sequential treatment, respectively. BCVA improved earlier than CMT improvements suggesting a new mechanism of action unlike anti-VEGF. There were no drug related SAEs in ALG-1001 groups.Conclusions : Primary endpoint of non-inferiority in BCVA was met with sequential dosing of a single bevacizumab treatment plus 3 doses of 1.0mg ALG-1001 vs 6 doses of 1.25 mg bevacizumab (≤3 letters difference) at week 20. ALG-1001 showed 12-week durability in all study subjects in sequential therapy arms." @default.
- W2913565900 created "2019-02-21" @default.
- W2913565900 creator A5009018104 @default.
- W2913565900 creator A5009809226 @default.
- W2913565900 creator A5009870635 @default.
- W2913565900 creator A5019125791 @default.
- W2913565900 creator A5028848967 @default.
- W2913565900 creator A5031577547 @default.
- W2913565900 creator A5034626761 @default.
- W2913565900 creator A5038057537 @default.
- W2913565900 creator A5058044536 @default.
- W2913565900 creator A5079798042 @default.
- W2913565900 creator A5085965174 @default.
- W2913565900 creator A5087203984 @default.
- W2913565900 date "2018-07-13" @default.
- W2913565900 modified "2023-10-18" @default.
- W2913565900 title "Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety & Efficacy of ALG-1001 (Luminate®) in Diabetic Macular Edema" @default.
- W2913565900 hasPublicationYear "2018" @default.
- W2913565900 type Work @default.
- W2913565900 sameAs 2913565900 @default.
- W2913565900 citedByCount "0" @default.
- W2913565900 crossrefType "journal-article" @default.
- W2913565900 hasAuthorship W2913565900A5009018104 @default.
- W2913565900 hasAuthorship W2913565900A5009809226 @default.
- W2913565900 hasAuthorship W2913565900A5009870635 @default.
- W2913565900 hasAuthorship W2913565900A5019125791 @default.
- W2913565900 hasAuthorship W2913565900A5028848967 @default.
- W2913565900 hasAuthorship W2913565900A5031577547 @default.
- W2913565900 hasAuthorship W2913565900A5034626761 @default.
- W2913565900 hasAuthorship W2913565900A5038057537 @default.
- W2913565900 hasAuthorship W2913565900A5058044536 @default.
- W2913565900 hasAuthorship W2913565900A5079798042 @default.
- W2913565900 hasAuthorship W2913565900A5085965174 @default.
- W2913565900 hasAuthorship W2913565900A5087203984 @default.
- W2913565900 hasConcept C118487528 @default.
- W2913565900 hasConcept C126322002 @default.
- W2913565900 hasConcept C134018914 @default.
- W2913565900 hasConcept C141071460 @default.
- W2913565900 hasConcept C142724271 @default.
- W2913565900 hasConcept C168563851 @default.
- W2913565900 hasConcept C203092338 @default.
- W2913565900 hasConcept C204787440 @default.
- W2913565900 hasConcept C27081682 @default.
- W2913565900 hasConcept C2776694085 @default.
- W2913565900 hasConcept C2777288759 @default.
- W2913565900 hasConcept C2777802072 @default.
- W2913565900 hasConcept C2779829184 @default.
- W2913565900 hasConcept C2908647359 @default.
- W2913565900 hasConcept C2985127711 @default.
- W2913565900 hasConcept C31760486 @default.
- W2913565900 hasConcept C535046627 @default.
- W2913565900 hasConcept C555293320 @default.
- W2913565900 hasConcept C71924100 @default.
- W2913565900 hasConcept C99454951 @default.
- W2913565900 hasConceptScore W2913565900C118487528 @default.
- W2913565900 hasConceptScore W2913565900C126322002 @default.
- W2913565900 hasConceptScore W2913565900C134018914 @default.
- W2913565900 hasConceptScore W2913565900C141071460 @default.
- W2913565900 hasConceptScore W2913565900C142724271 @default.
- W2913565900 hasConceptScore W2913565900C168563851 @default.
- W2913565900 hasConceptScore W2913565900C203092338 @default.
- W2913565900 hasConceptScore W2913565900C204787440 @default.
- W2913565900 hasConceptScore W2913565900C27081682 @default.
- W2913565900 hasConceptScore W2913565900C2776694085 @default.
- W2913565900 hasConceptScore W2913565900C2777288759 @default.
- W2913565900 hasConceptScore W2913565900C2777802072 @default.
- W2913565900 hasConceptScore W2913565900C2779829184 @default.
- W2913565900 hasConceptScore W2913565900C2908647359 @default.
- W2913565900 hasConceptScore W2913565900C2985127711 @default.
- W2913565900 hasConceptScore W2913565900C31760486 @default.
- W2913565900 hasConceptScore W2913565900C535046627 @default.
- W2913565900 hasConceptScore W2913565900C555293320 @default.
- W2913565900 hasConceptScore W2913565900C71924100 @default.
- W2913565900 hasConceptScore W2913565900C99454951 @default.
- W2913565900 hasIssue "9" @default.
- W2913565900 hasOpenAccess W2913565900 @default.
- W2913565900 hasRelatedWork W1775905963 @default.
- W2913565900 hasRelatedWork W1978882188 @default.
- W2913565900 hasRelatedWork W1997761243 @default.
- W2913565900 hasRelatedWork W2024586523 @default.
- W2913565900 hasRelatedWork W2084763396 @default.
- W2913565900 hasRelatedWork W2095826876 @default.
- W2913565900 hasRelatedWork W2099186776 @default.
- W2913565900 hasRelatedWork W2101485991 @default.
- W2913565900 hasRelatedWork W2115369775 @default.
- W2913565900 hasRelatedWork W2135140316 @default.
- W2913565900 hasRelatedWork W2246347597 @default.
- W2913565900 hasRelatedWork W2265954609 @default.
- W2913565900 hasRelatedWork W2377374529 @default.
- W2913565900 hasRelatedWork W2470811856 @default.
- W2913565900 hasRelatedWork W2763723789 @default.
- W2913565900 hasRelatedWork W2943604071 @default.
- W2913565900 hasRelatedWork W2981587847 @default.
- W2913565900 hasRelatedWork W3000367520 @default.
- W2913565900 hasRelatedWork W2156754995 @default.
- W2913565900 hasRelatedWork W2947205119 @default.
- W2913565900 hasVolume "59" @default.
- W2913565900 isParatext "false" @default.