NCT03635814

The Study to YD312 Tablet in Patients With Diabetic Macular Edema

Multi-center, Randomized, Double-blind, Dose-finding, Phase 2a Clinical Trial to Evaluate the Effecacy and Safety of YD312 Tablet in Patients With Diabetic Macular Edema

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: YD Global Life Science Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Macular Edema(DME)

Interventions

Type	Name	Description
DRUG	YD312 50mg	YD312 50mg \* 1 + placebo 6 tablets
DRUG	YD312 150mg	YD312 50mg \* 3 + placebo 6 tablets
DRUG	YD312 350mg	YD312 50mg \* 7 tablets
DRUG	Placebo	YD312 0mg \* 7 tabets

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-07-27
• Completion: 2020-03-20
• First posted: 2018-08-17
• Last updated: 2020-01-09

Locations

20 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study