Clinical Trial Search

Primary: Sensitivity(mtmDR) — 90.48; 95.65; 95.19 percentage of true positives

Primary: Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period — 35.0; 23.1 Percentage of participants

Primary: Percentage of Subjects With Vision Loss to 20/40 or Worse — 5; 3 Eyes — p=.76

Primary: Sensitivity Corrected for Enrichment — 87.2 percentage of true positives

Primary: The Best Corrected Visual Acuity (BCVA) — 67.6; 76.36 letters — p=<0.0001

Primary: Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye — 0.0; 1.9 percentage of participants

Primary: Change in Dark Adaptation, Rod Intercept — 0.3; -0.3 minutes — p=.70

Primary: Mean Change in Visual Acuity From Baseline — 2.8; 0.2 letters

Primary: Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36 — 5.0; 0; 4.8 percentage of subjects

Primary: Rate of Resolved Post-operative Vitreous Hemorrhage. — 6; 5 Participants

Primary: Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) — 0.2; 0.5 nM/hr

Primary: Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8…

Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 0; 0; 0; 0 Participants

Primary: The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography) — -83.8; 52.6; 11.3; 55.4…

Primary: The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group — 2.80; 0.13 dB

Primary: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye — 0.2; -4.2 Letters Read — p=<0.001

Primary: Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month — -25.2; -29.9; -58.9 micrometers — p=0.04

Primary: Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks — -4; 1; 2 Letter Score — p=<.001

Primary: Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36…

Primary: Number of Participant Who Had Baseline Eye Exam — 33 Participants

Primary: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale — 127; 124 Participants — p=0.8487

Primary: Development of PDR and/or DME (Whichever Came First) — 27; 75 Eyes

Primary: Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values — 45.6; 4.9…

Primary: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale — 161; 182 Participants — p=0.1994

Primary: Change in Macular Drusen Volume — 0.05; 0.11; 20.0; 9.0 mm^3

Primary: Treatment or "Failure" Defined as Vitrectomy — 12; 17 percentage of participants — p=0.37

Primary: Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at…

Primary: Best-corrected Visual Acuity — 1.25; 1.29; 1.16 LogMAR

Primary: Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters…

Primary: Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps — 0; 5; 2 eyes — p=0.495