Change in drusen volume as a novel clinical trial endpoint for the study of complement inhibition in age-related macular degeneration

Ophthalmic Surgery, Lasers & Imaging Retina
Carlos Alexandre de Amorim Garcia FilhoPhilip J Rosenfeld

Abstract

To evaluate the change in drusen volume following treatment with eculizumab, a systemic inhibitor of complement component 5. Single-center, prospective, randomized, double-masked clinical trial. Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 26 weeks. decrease in drusen volume of at least 50% at 26-week follow-up. Mean drusen cube root volumes were 0.49 mm and 0.47 mm (P = .64) at baseline and 0.51 mm and 0.42 mm (P = .17) at 26 weeks in the eculizumab and placebo groups, respectively. In the placebo group, one eye had a decrease in drusen volume of at least 50% and two eyes developed neovascularization through 26 weeks. Systemic complement inhibition with eculizumab did not significantly reduce drusen volume. Drusen growth was dependent on the number of complement at-risk alleles. Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatment’s ability to prevent drusen growth, neovascularization, and the formation of geographic atrophy over 1 year.

Associated Clinical Trials

Jul 9, 2009·Philip J. Rosenfeld, MD, PhD, Philip J. Rosenfeld, MD, PhD

References

Jan 1, 1990·Epidemiology·K J Rothman
May 1, 1990·Epidemiology·K J RothmanN A Dreyer
Nov 1, 1990·Epidemiology·K J Rothman
Jan 1, 1990·Journal of Clinical Epidemiology·C Poole, K J Rothman
Jan 1, 1990·Journal of Clinical Epidemiology·S F Lanes, K J Rothman
Dec 22, 2004·The Journal of Immunology : Official Journal of the American Association of Immunologists·Puran S BoraNalini S Bora
May 5, 2005·Proceedings of the National Academy of Sciences of the United States of America·Gregory S HagemanRando Allikmets
Nov 16, 2005·Archives of Ophthalmology·Matthew D DavisUNKNOWN Age-Related Eye Disease Study Group
Nov 16, 2005·Archives of Ophthalmology·Frederick L FerrisUNKNOWN Age-Related Eye Disease Study (AREDS) Research Group
Feb 3, 2006·Proceedings of the National Academy of Sciences of the United States of America·Miho NozakiJayakrishna Ambati
Jul 20, 2006·The Journal of Immunology : Official Journal of the American Association of Immunologists·Nalini S BoraPuran S Bora
Sep 23, 2006·The New England Journal of Medicine·Peter HillmenLucio Luzzatto
Apr 4, 2007·BMJ : British Medical Journal·Ignacio Ferreira-GonzálezGordon H Guyatt
Jul 20, 2007·The New England Journal of Medicine·John R W YatesUNKNOWN Genetic Factors in AMD Study Group
Aug 8, 2008·European Journal of Human Genetics : EJHG·Jesen A FagernessJohanna M Seddon
Nov 26, 2009·Ophthalmic Surgery, Lasers & Imaging : the Official Journal of the International Society for Imaging in the Eye·Thomas R FribergUNKNOWN PTAMD Study Group
Jan 21, 2010·JAMA : the Journal of the American Medical Association·George Tomlinson, Allan S Detsky
May 26, 2011·Seminars in Ophthalmology·Zohar YehoshuaThomas A Albini
Aug 27, 2011·Immunobiology·S KhandhadiaA J Lotery
Mar 10, 2012·Clinical Journal of the American Society of Nephrology : CJASN·Andrew S BombackGerald B Appel
Jul 4, 2012·Ophthalmology·Maureen G Maguire
Jan 22, 2013·Ophthalmology·Frederick L FerrisUNKNOWN Beckman Initiative for Macular Research Classification Committee
Mar 9, 2013·Investigative Ophthalmology & Visual Science·Zohar YehoshuaPhilip J Rosenfeld
Mar 21, 2013·Ophthalmic Surgery, Lasers & Imaging Retina·Zohar YehoshuaPhilip J Rosenfeld

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Citations

Jun 28, 2018·Scientific Reports·Rosario Fernandez-Godino, Eric A Pierce
Apr 30, 2014·Orvosi hetilap·Krisztián Kórász
May 23, 2017·F1000Research·Francesco BandelloGiuseppe Querques
Jun 4, 2019·Frontiers in Immunology·Dong Ho ParkJohn D Lambris
Sep 10, 2020·Journal of Clinical Medicine·Sander De BruyneJoris R Delanghe
Jun 10, 2015·Ophthalmic Surgery, Lasers & Imaging Retina·Mariana R ThorellPhilip J Rosenfeld
Feb 22, 2021·Progress in Retinal and Eye Research·Sarah de JongAnneke I den Hollander
Sep 6, 2015·Clinical Immunology : the Official Journal of the Clinical Immunology Society·Edimara S ReisJohn D Lambris
Jan 30, 2021·Investigative Ophthalmology & Visual Science·Ling ChenChristine A Curcio
May 19, 2021·Scientific Reports·Donita L GarlandRosario Fernandez-Godino
Jul 3, 2021·International Journal of Molecular Sciences·Young Gun ParkIn-Beom Kim
Aug 10, 2021·Journal of Immunology Research·Shuqi QinYanling Wang
Dec 9, 2021·Clinical & Experimental Optometry : Journal of the Australian Optometrical Association·Heather G MackSamantha Fraser-Bell

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