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Yasir Sepah, Diana V Do, David Callanan, Victor H Gonzalez, Lawrence Halperin, Brian B Berger, Mostafa Saad Hanout, Peter Hnik, Quan Dong Nguyen; Demographics and Baseline Characteristics of the iDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema with Involvement of the FoveAL Center. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1758.
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iCo-007 is a 2nd generation anti-sense inhibitor targeting C-raf kinase mRNA. C-raf kinase plays a key role in the MAP kinase signaling pathway, involved in angiogenesis and vascular permeability. The Phase I study demonstrated bioactivity of intravitreal iCo-007 in a number of eyes with diffuse diabetic macular edema (DME). The design, demographics, and baseline characteristics of the iDEAL Study are described.
Subjects 18 years of age with ME secondary to type 1 or 2 diabetes across 28 sites in the US were enrolled in the Study. Key inclusion criteria were 1) best corrected visual acuity (BCVA) of ≤20/32 or ≥20/320; 2) central foveal thickness (CFT) of >250µ on time-domain OCT at baseline (BL); 3) non-proliferative diabetic retinopathy (NPDR) or inactive PDR. Patients were randomized to 4 groups in a 1:1:1:1 ratio. Groups I and II receive 350µg and 700µg of iCo-007 at BL and month (M) 4, respectively. Group III receives 350µg of iCo-007 at BL and M4 with mandatory focal/grid laser treatment 7 days after BL iCo-007, and optional laser at M4 + 7 days. Group IV receives ranibizumab (0.5mg) at BL and M4 followed 14 days later (BL + 14 days and M4 + 14 days) by iCo-007 350µg. Re-treatment at M8 (primary end point) is optional for all groups based on predetermined retreatment criteria. Primary objective of the study is the change in VA from BL to M8. Secondary objectives include VA change from BL to M12, changes in FTh from BL to M8 and M12, along with safety and tolerability.
The iDEAL study has finished enrollment with 187 subjects randomized (185 treated). Mean age of subjects is 62.2; 102 males (55.1%), 144 are Caucasians (77.8%). Mean BL VA/CFT were 57.5/426µm in group I, 59.5/450µm in group II, 61.1/422µm in group III, and 61.2/412µm in group IV. Mean BL HbA1c was 7.5%, 7.8%, 7.7%, and 7.4% in groups I, II, III and IV, respectively. 34.1% of study eyes were treatment naive.
Demographics of subjects in the iDEAL study are consistent with those reported from other phase II/III studies for DME. Therefore, safety and efficacy outcomes of the study may be generalizable to other populations with DR and DME.
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