Original articlePrimary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
Section snippets
Materials and Methods
This is a phase II, randomized clinical trial conducted at 14 sites in the United States through an investigator-initiated Investigational New Drug granted by the Food and Drug Administration. The study adhered to the guidelines of the Declaration of Helsinki, and the protocol and consent form were approved by a local investigational review board for some sites and by the Western Institutional Review Board for others. Each subject provided written informed consent. The study was monitored by an
Baseline Characteristics of the Study Groups
The baseline characteristics of the 126 patients who were randomized in the study are listed in Table 1. The 3 groups were balanced with respect to mean BCVA, excess foveal thickness, and glycosylated hemoglobin. At baseline, 78 of the 126 patients had hypercholesterolemia that required treatment, and this was balanced among the groups: 26 patients in group 1, 29 patients in group 2, and 23 patients in group 3. There were no significant differences in any baseline characteristics among the 3
Discussion
We previously showed that VEGF plays an important role in the pathogenesis of DME and provided preliminary evidence suggesting that intraocular injections of ranibizumab provides benefit in patients with DME.6 Ten patients with DME who received injections of 0.5 mg of ranibizumab at baseline and months 1, 2, 4, and 6 showed a mean improvement in visual acuity of 12.3 letters read and a reduction in mean excess foveal thickness from 503 μm to 257 μm, constituting an elimination of 85% of edema.
References (10)
- et al.
Intravitreal sustained release of VEGF causes retinal neovascularization in rabbits and breakdown of the blood-retinal barrier in rabbits and primates
Exp Eye Res
(1997) - et al.
Supplemental oxygen improves diabetic macular edema: a pilot study
Invest Ophthalmol Vis Sci
(2003) - et al.
Upregulation of vascular endothelial growth factor in ischemic and non-ischemic human and experimental retinal disease
Histol Histopathol
(1997) - et al.
Quantitative assessment of the integrity of the blood-retinal barrier in mice
Invest Ophthalmol Vis Sci
(2002) Reduction of diabetic macular edema by oral administration of the kinase inhibitor PKC412
Invest Ophthalmol Vis Sci
(2004)
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2021, Experimental Eye ResearchCitation Excerpt :The efficacy of focal/grid photocoagulation laser therapy in reducing the risk of visual loss due to DME was demonstrated in an early treatment diabetic retinopathy study (ETDRS) (Early photocoagulation for diabetic retinopathy, 1991), and represents the current standard of care (Aiello et al., 2010). Recent studies have demonstrated statistically significant efficacy of intravitreal anti-VEGF injections in improving visual acuity and in reducing retinal thickness in patients with DME (Arevalo et al., 2007; Nguyen et al., 2009, 2010). This is likely to be attributable to the role of VEGF in increasing vascular permeability as DME patients presenting with greater macular leakage have elevated levels of VEGF (Funatsu et al., 2003, 2005).
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Manuscript no. 2009-69.
Quan Dong Nguyen, MD, MSc, and Syed Mahmood Shah, MBBS, contributed equally to the manuscript.
Sponsored by the Juvenile Diabetes Research Foundation and Genentech, Inc.
QDN is a recipient of a K23 Career Development Award (EY 13552) from the National Eye Institute. PAC is the George S. and Dolores Doré Eccles Professor of Ophthalmology and Neuroscience.
Financial Disclosure(s): The author(s) have made the following disclosure(s): QDN and PAC have served as members of Expert Panels for Genentech, Inc. without receiving an honorarium during the time of this study, but JHU has recently negotiated a contract through which JHU receives compensation. QDN is a consultant for Bausch and Lomb and has research support from Genentech, Inc., and Regeneron, Inc. PAC serves on the data and safety monitoring committee for a phase III trial sponsored by Regeneron, Inc., and has research support from Genentech, Alimera, and CoMentis for diabetic macular edema trials. Diana Do receives research support from Genentech. These activites are being managed by the Conflict of Interest Committee of the Johns Hopkins University School of Medicine. JSH is a consultant for Genentech, Alcon, Allergan, Bausch and Lomb, Eyemaginations, Fovea, Genzyme, Heidelburg, IScience, ISTA, Jerini, LPath, NeoVista, Nodal Vision, Novagali, Novartis, Optherion, Oxigene, Paloma, Pfizer, Regeneron, Resolvyx, Schering Plough, Scyfix, and VisionCare and has received honoriaria from Genentech, Heidelberg, Jerini, NeoVista, Optimedica, and Regeneron. JL has received honoriaria from Genentech. DB is a consultant and has received honoraria from Genentech, Novartis, Alcon, Allergan, and Pfizer. PA is a consultant for Genentech.
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READ-2 Investigators and Team Members appear in Appendix 1 (available at http://aaojournal.org).