July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety & Efficacy of ALG-1001 (Luminate®) in Diabetic Macular Edema
Author Affiliations & Notes
  • Hugo Quiroz-Mercado
    Retina, Asociacion para Evitar la Ceguera en Mexico, Denver, Colorado, United States
  • David S Boyer
    Retina-Vitreous Associates Medical Group, Los Angeles, California, United States
  • Peter A Campochiaro
    The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
  • Jeffrey S. Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts, United States
  • Peter K Kaiser
    Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States
  • Julie Kornfield
    Caltech, Pasadena, California, United States
  • Baruch D Kuppermann
    Ophthalmology, Gavin Herbert Eye Institute, UCI, Irvine, California, United States
  • Vicken H Karageozian
    Allegro Ophthalmics, San Juan Capistrano, California, United States
  • Hampar L Karageozian
    Allegro Ophthalmics, San Juan Capistrano, California, United States
  • Lisa Karageozian
    Allegro Ophthalmics, San Juan Capistrano, California, United States
  • John Y Park
    Allegro Ophthalmics, San Juan Capistrano, California, United States
  • Melvin Sarayba
    Allegro Ophthalmics, San Juan Capistrano, California, United States
  • Footnotes
    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)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1960. doi:
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    • Get 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.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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