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Diabetic Macular Edema(DME)Phase 2NCT03635814

The Study to YD312 Tablet in Patients With Diabetic Macular Edema

A Phase 2 study testing YD312 50mg, YD312 150mg and YD312 350mg in people with Diabetic Macular Edema(DME), run by YD Global Life Science Co., Ltd. at 20 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetic Macular Edema(DME)
What is being tested?
YD312 50mg, YD312 150mg and YD312 350mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
20 sitesin 2 countries
Study dates
19 Oct 2017to 20 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 34Show fewer
  • 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)]
  • Severe heart failure (NYHA class III/IV)
  • Malignant tumor within 5 years before randomization
  • Subject who is known to be HIV positive, is active hepatitis B patient or carrier, or is hepatitis C patient
  • 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.
  • Unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening
  • 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)
  • 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.
  • Subject, at the discretion of the investigator, who is unsuitable to participate in the study.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States13 sites

  • Elman Retina Group

    Baltimore, Maryland, 21237

  • Phensylvania Retina Specialists

    Camp Hill, Pennsylvania, 17011

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Retina Associates

    Chicago, Illinois, 60126

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • South Flolida Clinical Trials

    Hialeah, Florida, 33106

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Impact Clinical Trials LV

    Las Vegas, Nevada, 89106

  • AXIS Clinical Trials

    Los Angeles, California, 90036

  • NY Clinical Trials

    New York, New York, 10022

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23502

  • Vitro-Retinal Consultants, Inc

    Painesville, Ohio, 44077

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

Other trials in United States

South Korea7 sites

  • Inje National University Busan Park Hospital

    Busan, Jin-gu, 47392

  • Kyungpook National University Hospital

    Daegu, Chung-gu, 41944

  • Chungnam National University Hospital

    Daejeon, Chung-gu, 35015

  • Hanyang University Guri Medical Center

    Guri-si, Kyeonggi-do, 11923

  • Seoul National University Bundang Hospital

    Seongnam-si, Kyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, Gangmam-gu, 06351

  • Kangnam Severance Hospital

    Seoul, Gangnam-gu, 06273

Other trials in South Korea

About this study

Official title: 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

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.

Read the 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.

Being tested
YD312 50mg, YD312 150mg, YD312 350mg, Placebo
Keywords
Clinicaltrial, DME, DR, AMD, imatinib mesylate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YD312 50mgDrug

    YD312 50mg * 1 + placebo 6 tablets

  • YD312 150mgDrug

    YD312 50mg * 3 + placebo 6 tablets

  • YD312 350mgDrug

    YD312 50mg * 7 tablets

  • PlaceboDrug

    YD312 0mg * 7 tabets

Study groups in NCT03635814
Study groupRoleWhat they receive
YD312 drug treatmentExperimentalFrom 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.
Receives: Drug: YD312 50mg; Drug: YD312 150mg; Drug: YD312 350mg
YD312 placebo drug treatmentPlacebo comparatorFrom 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ETDRS BCVA latter score from baseline at Week 12 ( ETDRS chart reading at least 3 letters)

    Measured: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)

Secondary outcomes (3)

  1. Change in ETDRS BCVA latter score from baseline at Weeks 4 and 8

    Measured: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)

  2. 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

    Measured: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)

  3. Change in CST from baseline at Weeks 4, 8, and 12

    Measured: BCVA ERDRS measure at V1(screening), V2(baseline,week0), V3(week4), V4(week8), V5(week12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start19 Oct 2017
  3. Primary completion27 Jul 2018
  4. Study completion20 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects who finally meet inclusion/exclusion criteria will be randomized into lower dose group (YD312 Tablet 50 mg), middle dose group (YD312 Tablet 150 mg), higher dose group (YD312 Tablet 350 mg), and placebo group as a ratio of 1:1:1:1 and the relevant investigational product will be administered for 12 weeks.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635814
Sponsor's protocol ID
YD312-01-P2
Status last verified
Jan 2020
First submitted
14 Aug 2018
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YD312 50mg, YD312 150mg and YD312 350mg in people with Diabetic Macular Edema(DME), run by YD Global Life Science Co., Ltd. at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.

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