The Study to YD312 Tablet in Patients With Diabetic Macular Edema

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema(DME)

In brief

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.

Key facts

Study ID

NCT03635814

Run by

YD Global Life Science Co., Ltd.

People needed

100

Starts

2017-10-19

Expected to finish

2020-03-20

Last updated by the study team

2020-01-09

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screening Inclusion Criteria
• Study subjects must be eligible for the following criteria at screening:
• Subject who is male or female ≥ 19 years of age
• Subject who has a diagnosis of Type 1 or 2 diabetes
• Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula
• Subject who has voluntarily signed an informed consent form
• Randomization Inclusion Criteria
• Study eye must be eligible for the following criteria at randomization:
• Subject who has study eye with central subfield thickness (CST) of ≥ 300 μm on optical coherence tomography (OCT)
• Subject who has study eye with an early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score ranging from 39 to 78, inclusive (approximate Snellen equivalent of 20/32 - 20/160)

You may not qualify if…

• Subject who has study eye with any of the following criteria:
• Subject whose primary cause of macular edema is non-diabetic disease/condition (e.g., cataract extraction, vitreomacular interface abnormalities)
• Subject who is expected to have no improvement of decreased visual acuity in the opinion of investigator, even if macular edema is resolved (e.g., foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate)
• Subject who has proliferative diabetic retinopathy.
• Subject who took the following within 3 months before randomization
• ① Focal/grid laser photocoagulation
• ② Intravitreal/circumbulbar corticosteroid, anti-VEGF and pro-VEGF (but, no wash-out period is required for the corticosteroid eyedrops)
• Subject who took panretinal photocoagulation (PRP) or intravitreal dexamethasone implant within 6 months before randomization
• Subject who has a history of vitrectomy
• Subject who took major ophthalmic surgeries (all intraocular surgeries including cataract extraction and scleral buckle) within 6 months before randomization
• Subject who had systemic treatment of corticosteroid or anti-VEGF within 3 months before randomization.
• Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization
• Subject who is suspected to require administration/treatment of drug/procedure that may affect the efficacy evaluation before the participation of clinical trial or during clinical trial (refer to '10.4 Combination Therapy and Contraindication').
• Subject who has the following illness or abnormal laboratory test values:
• Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient
• Subject who has uncontrolled hypertension (SBP > 160 mmHg or DBP >100 mmHg)
• Subject who has uncontrolled diabetes (HbA1c > 10.0%)
• Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) > 24 mmHg on medication or according to the investigator's judgment)
• ANC < 1.5 × 109/L
• Platelet < 125 × 109/L
• Total bilirubin > 1.5 × ULN
• AST or ALT > 2 × ULN
• Clcr* < 40 mL/min
• Clcr (Cockcroft-Gault formula)
• = [(140 - age) x weight(kg) (x 0.85 for females)] / [72 x serum creatinine (Scr) (mg/dL)]

Where it is running

• AXIS Clinical Trials — Los Angeles, California, United States
• South Flolida Clinical Trials — 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
• WR-Clinsearch, LLC — Chattanooga, Tennessee, United States
• Clinical Trials of Texas, Inc — San Antonio, Texas, United States
• Wagner Macula & Retina Center — Norfolk, Virginia, United States
• Kyungpook National University Hospital — Daegu, Chung-gu, South Korea
• Chungnam National University Hospital — Daejeon, Chung-gu, South Korea
• Samsung Medical Center — Seoul, Gangmam-gu, South Korea
• Kangnam Severance Hospital — Seoul, Gangnam-gu, South Korea
• Inje National University Busan Park Hospital — Busan, Jin-gu, South Korea
• Hanyang University Guri Medical Center — Guri-si, Kyeonggi-do, South Korea
• Seoul National University Bundang Hospital — Seongnam-si, Kyeonggi-do, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.