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Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety & Efficacy of ALG-1001 (Luminate®) in Diabetic Macular Edema

Quiroz-Mercado, Hugo and Boyer, David S. and Campochiaro, Peter A. and Heier, Jeffrey S. and Kaiser, Peter K. and Kornfield, Julie and Kuppermann, Baruch D. and Karageozian, Vicken H. and Karageozian, Hampar L. and Karageozian, Lisa and Park, John Y. and Sarayba, Melvin (2018) Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety & Efficacy of ALG-1001 (Luminate®) in Diabetic Macular Edema. Investigative Ophthalmology and Visual Science, 59 (9). Art. No. 1960. ISSN 0146-0404. https://resolver.caltech.edu/CaltechAUTHORS:20180926-125651369

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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.


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ORCID:
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Kornfield, Julie0000-0001-6746-8634
Additional Information:© 2018 This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. Commercial Relationships Hugo Quiroz-Mercado, Allegro Ophthalmics (I), Allegro Ophthalmics (C); David Boyer, Aerpio (F), Aerpio (C), Allegro Ophthalmics (I), Allegro Ophthalmics (C), Allergan (F), Allergan (C), Bayer (F), Bayer (C), Boehringer-Ingelheim (F), Boehringer-Ingelheim (C), Genentech (F), Genentech (C), Novartis (F), Novartis (C), Nuerotech (I), Nuerotech (C), Ohr (I), Ohr (C), Ophthotech (I), Regeneron (F), Regeneron (C), River Vision (F), River Vision (C), Roche (F), Roche (C); Peter Campochiaro, Aerpio (F), Aerpio (C), Alimera (F), Alimera (C), Allegro Ophthalmics (F), Allegro Ophthalmics (I), Allegro Ophthalmics (C), Allergan (F), Allergan (C), Applied Genetic Technologies (C), AsclipiX (F), AsclipiX (C), Genentech/Roch (C), Genentech/Roche (F), Genzyme (F), GlaxoSmithKline (F), Graybug (I), Intrexon (C), Merck (C), Oxford Biomedica (F), Regeneron (F), Regenxbio (F), Regenxbio (C), Rxi (F), Rxi (C); Jeffrey Heier, Aerpio (F), Aerpio (C), Allegro Ophthalmics (I), Asclepix (C), Bayer (C), Daiichi-Sankyo (C), Daiichi-Sankyo (F), Genentech/Roche (C), Genentech/Roche (F), Novartis (C), Regeneron (C), Regeneron (F), SciFluor (C), SciFluor (F); Peter Kaiser, Aerie (C), Aerpio (C), Alcon (C), Allegro Ophthalmics (I), Allegro Ophthalmics (C), Allergan (C), Bayer (C), Biogen Idec (C), Boerenger Ingelheim (C), Galecto Biotech (C), Hospira (C), jCyte (C), Kanghong (C), Kodiak (C), Novartis (C), Ohr (C), Omeros (C), Regeneron (C), Retinal Sciences (C), Santen (C), SciFluor (C), Shire (C), Stealth Biotherapeutics (C), Thrombogenics (C); Julie Kornfield, Allegro Ophthalmics (I), Allegro Ophthalmics (C); Baruch Kuppermann, Aerpio (C), Alcon (C), Alcon (F), Alimera (C), Alimera (F), Allegro Ophthalmics (F), Allegro Ophthalmics (I), Allegro Ophthalmics (C), Allergan (C), Allergan (F), Ampio (C), Catalyst (C), Dose (C), Eyedaptic (C), Genentech (F), Genetech (C), Glaukos (C), Ionis (C), J-Cyte (C), J-Cyte (F), Novartis (C), Ophthotech (C), Ophthotech (F), Regeneron (C), Regeneron (F); Vicken Karageozian, Allegro Ophthalmics (I), Allegro Ophthalmics (E); Hampar Karageozian, Allegro Ophthalmics (I), Allegro Ophthalmics (E); Lisa Karageozian, Allegro Ophthalmics (I), Allegro Ophthalmics (E); John Park, Allegro Ophthalmics (I), Allegro Ophthalmics (E); Melvin Sarayba, Allegro Ophthalmics (I), Allegro Ophthalmics (E). Support: None.
Issue or Number:9
Record Number:CaltechAUTHORS:20180926-125651369
Persistent URL:https://resolver.caltech.edu/CaltechAUTHORS:20180926-125651369
Official Citation:Hugo Quiroz-Mercado, David S Boyer, Peter A Campochiaro, Jeffrey S. Heier, Peter K Kaiser, Julie Kornfield, Baruch D Kuppermann, Vicken H Karageozian, Hampar L Karageozian, Lisa Karageozian, John Y Park, Melvin Sarayba; Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety & Efficacy of ALG-1001 (Luminate®) in Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1960
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:89962
Collection:CaltechAUTHORS
Deposited By: Tony Diaz
Deposited On:26 Sep 2018 21:39
Last Modified:03 Oct 2019 20:20

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