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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 Yasir Sepah, MBBS 1 ; Diana Do, MD 1 ; David Callanan, MD 2 ; Victor Gonzalez, MD 3 ; Lawrence Halperin, MD 4 ; Brian Berger, MD 5 ; Mostafa Hanout, MD 1 ; Peter Hnik, MD, MHSc 6 and Quan Dong Nguyen, MD, MSc 1 1- Ocular Imaging Research and Reading Center, Truhlsen Eye Institute, UNMC, NE, USA. 2- Texas Retina Associates, Arlington, TX, USA .3- Valley Retina Institute, TX, USA 4- Retina Group of Florida, FL, USA. 5- Retina Research Center, TX, USA 6- iCo Therapeutics Inc., Vancouver, Ca 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. Purpose Results Conclusion 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. Methods 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. Retreatment 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 study finished enrollment with 187 subjects randomized (185 treated). Demographic Characteristic Group 1 N=47 Group 2 N= 46 Group 3 N= 47 Group 4 N= 45 Total N= 185 Gender Male 20 (42.6%) 27 (58.7%) 27 (57.4%) 28 (62.2%) 102 (55.1%) Female 27 (57.4%) 19 (41.3%) 20 (42.6%) 17 (37.8) 83 (44.9%) Age (yrs) Mean (SD) 63.3 62.7 61.4 61.2 62.2 Median (Q1, Q3) 62 (55, 67) 64 (56.5, 70) 65 (55, 70) 63 (59, 65.5) 63 (56, 68) Min-Max 41-83 46-83 46-88 42-75 41-88 Race American Indian / Alaskan Native 1 (2.2%) 1 (2.1%) 1 (2.2%) 3 (1.6%) Native Hawaiian / Pacific Islander 1 (2.1%) 1 (0.5 %) Asian 3 (6.4%) 3 (6.5%) 4 (8.9%) 10 (5.4%) Caucasian 35 (74.5%) 34 (73.9%) 42 (89.4%) 33 (73.3%) 144 (77.8%) African American 7 (14.9%) 3 (6.5%) 1 (2.1%) 4 (8.9%) 15 (8.1%) Other 1 (2.1%) 5 (10.9%) 3 (6.4%) 3 (6.7%) 12 (6.5%) Ethnicity Hispanic or Latino 12 (25.5%) 7 (15.2%) 9 (19.1%) 11 (24.4%) 39 (21.1%) Not Hispanic or Latino 35 (74.5) 39 (84.8%) 38 (80.9%) 35 (75.6%) 146 (78.9%) Financial Disclosures Financial disclosures of the authors can be found on the abstract proof on the ARVO website: www.arvo.org
