This study objectives is to evaluate the efficacy of YD312 to improve visual acuity in patients with diabetic macular edema (DME) compared to placebo and determine optimal dose of phase 2b study.
These study results present the possibility that imatinib can be used as a new DME inhibiting agent by involving VEGF-independent ocular angiogenesis, not action points of existing agents, in effectively inhibiting excessive vascular angiogenesis observed in oxygen-induced retinopathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
YD312 50mg \* 1 + placebo 6 tablets
YD312 50mg \* 3 + placebo 6 tablets
YD312 50mg \* 7 tablets
AXIS Clinical Trials
Los Angeles, California, United States
South Flolida Clinical Trials
Change in ETDRS BCVA latter score from baseline at Week 12 ( ETDRS chart reading at least 3 letters)
Time frame: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Change in ETDRS BCVA latter score from baseline at Weeks 4 and 8
Time frame: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Improvement or worsening rate of ETDRS BCVA from baseline at Weeks 4, 8, and 12
* Proportion of improved subjects: ≥ 1 letter score increase, ≥ 10 letter score increase, ≥ 15 letter score increase * Proportion of worsened subjects: ≥ 5 letter score decrease, ≥ 10 letter score decrease, ≥ 15 letter score decrease
Time frame: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Change in CST from baseline at Weeks 4, 8, and 12
Time frame: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
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YD312 0mg \* 7 tabets
Hialeah, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Retina Associates
Chicago, Illinois, United States
Elman Retina Group
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Impact Clinical Trials LV
Las Vegas, Nevada, United States
NY Clinical Trials
New York, New York, United States
Vitro-Retinal Consultants, Inc
Painesville, Ohio, United States
Phensylvania Retina Specialists
Camp Hill, Pennsylvania, United States
...and 10 more locations