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YD312 drug treatment for Diabetic Macular Edema
Phase 2
Waitlist Available
Research Sponsored by YD Global Life Science Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bcva erdrs measure at v1(screening), v2(baseline,week0), v3(week4), v4(week8), v5(week12)
Awards & highlights
Study 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.
Eligible Conditions
- Diabetic Macular Edema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ bcva erdrs measure at v1(screening), v2(baseline,week0), v3(week4), v4(week8), v5(week12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~bcva erdrs measure at v1(screening), v2(baseline,week0), v3(week4), v4(week8), v5(week12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ETDRS BCVA latter score from baseline at Week 12 ( ETDRS chart reading at least 3 letters)
Secondary outcome measures
Change in CST from baseline at Weeks 4, 8, and 12
Change in ETDRS BCVA latter score from baseline at Weeks 4 and 8
Improvement or worsening rate of ETDRS BCVA from baseline at Weeks 4, 8, and 12
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: YD312 drug treatmentExperimental Treatment3 Interventions
From the date when dispensed, investigational products will be dosed once a day at similar time to the first dosing time with meals and much water.
Group II: YD312 placebo drug treatmentPlacebo Group1 Intervention
From the date when dispensed, investigational products will be dosed once a day at similar time to the first dosing time with meals and much water.
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Who is running the clinical trial?
YD Global Life Science Co., Ltd.Lead Sponsor
Frequently Asked Questions
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