Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03635814
Other study ID # YD312-01-P2
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2017
Est. completion date March 20, 2020

Study information

Verified date January 2020
Source YD Global Life Science Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date March 20, 2020
Est. primary completion date July 27, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Screening Inclusion Criteria

Study subjects must be eligible for the following criteria at screening:

1. Subject who is male or female = 19 years of age

2. Subject who has a diagnosis of Type 1 or 2 diabetes

3. Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula

4. Subject who has voluntarily signed an informed consent form

2. Randomization Inclusion Criteria

Study eye must be eligible for the following criteria at randomization:

1. Subject who has study eye with central subfield thickness (CST) of = 300 µm on optical coherence tomography (OCT)

2. 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)

Exclusion Criteria:

1. Subject who has study eye with any of the following criteria:

1. Subject whose primary cause of macular edema is non-diabetic disease/condition (e.g., cataract extraction, vitreomacular interface abnormalities)

2. 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)

3. Subject who has proliferative diabetic retinopathy.

4. Subject who took the following within 3 months before randomization

? Focal/grid laser photocoagulation

? Intravitreal/circumbulbar corticosteroid, anti-VEGF and pro-VEGF (but, no wash-out period is required for the corticosteroid eyedrops)

5. Subject who took panretinal photocoagulation (PRP) or intravitreal dexamethasone implant within 6 months before randomization

6. Subject who has a history of vitrectomy

7. Subject who took major ophthalmic surgeries (all intraocular surgeries including cataract extraction and scleral buckle) within 6 months before randomization

2. Subject who had systemic treatment of corticosteroid or anti-VEGF within 3 months before randomization.

3. Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization

4. 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').

5. Subject who has the following illness or abnormal laboratory test values:

1. Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient

2. Subject who has uncontrolled hypertension (SBP > 160 mmHg or DBP >100 mmHg)

3. Subject who has uncontrolled diabetes (HbA1c > 10.0%)

4. Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) > 24 mmHg on medication or according to the investigator's judgment)

5. ANC < 1.5 × 109/L

6. Platelet < 125 × 109/L

7. Total bilirubin > 1.5 × ULN

8. AST or ALT > 2 × ULN

9. 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)]

10. Severe heart failure (NYHA class III/IV)

11. Malignant tumor within 5 years before randomization

12. Subject who is known to be HIV positive, is active hepatitis B patient or carrier, or is hepatitis C patient

13. Ocular inflammatory diseases such as uveitis, conjunctivitis, and blepharitis in either eye. However, the participation of subject in this study is considered at the discretion of investigator.

14. Unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening

6. Pregnant woman, lactating woman, or female or male subject of childbearing potential

*hormonal contraceptives, intrauterne contraceptive device, sterilization of spouse (e.g., vasectomy, tubal ligation), double-barrier method (e.g., combinational use of spermicides and condoms, diaphragm, contraceptive sponge, of FemCap)

7. Subject who took administraion/procedure of other investigational products or medical devices within longer period between 30 days before screening or over 5time half-life.

8. Subject, at the discretion of the investigator, who is unsuitable to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
YD312 50mg
YD312 50mg * 1 + placebo 6 tablets
YD312 150mg
YD312 50mg * 3 + placebo 6 tablets
YD312 350mg
YD312 50mg * 7 tablets
Placebo
YD312 0mg * 7 tabets

Locations

Country Name City State
Korea, Republic of Inje National University Busan Park Hospital Busan Jin-gu
Korea, Republic of Kyungpook National University Hospital Daegu Chung-gu
Korea, Republic of Chungnam National University Hospital Daejeon-si Chung-gu
Korea, Republic of Hanyang University Guri Medical Center Guri-si Kyeonggi-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Kyeonggi-do
Korea, Republic of Kangnam Severance Hospital Seoul Gangnam-gu
Korea, Republic of Samsung Medical Center Seoul Gangmam-gu
United States Elman Retina Group Baltimore Maryland
United States Phensylvania Retina Specialists Camp Hill Pennsylvania
United States WR-Clinsearch, LLC Chattanooga Tennessee
United States Retina Associates Chicago Illinois
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States South Flolida Clinical Trials Hialeah Florida
United States Florida Retina Consultants Lakeland Florida
United States Impact Clinical Trials LV Las Vegas Nevada
United States AXIS Clinical Trials Los Angeles California
United States NY Clinical Trials New York New York
United States Wagner Macula & Retina Center Norfolk Virginia
United States Vitro-Retinal Consultants, Inc Painesville Ohio
United States Clinical Trials of Texas, Inc San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
YD Global Life Science Co., Ltd.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ETDRS BCVA latter score from baseline at Week 12 ( ETDRS chart reading at least 3 letters) BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Secondary Change in ETDRS BCVA latter score from baseline at Weeks 4 and 8 BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Secondary 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
BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)
Secondary Change in CST from baseline at Weeks 4, 8, and 12 BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)