Diabetic Macular Edema MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Sponsors
CELLTRION Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following criteria to be enrolled in this study: 1. Male or female patient aged =18 years. 2. Patient who has type 1 or 2 DM. 3. Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography [OCT] central subfield) in the study eye. 4. Patient whose central subfield retinal thickness is =350 µm as assessed by OCT based on central results in the study eye at Screening. 5. Patient who has BCVA score of 73 to 34 (approximate Snellen equivalent of 20/40 to 20/200) using ETDRS charts in the study eye at Screening and Day 1 (for more detailed BCVA procedures, see the study procedure manual). 6. Decrease in vision determined to be primarily the result of DME in the study eye. 7. Patient and/or their legally authorized representative are informed and will be given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form (ICF) before any specific procedures. 8. Female patient must agree to use highly effective methods of contraception consistent with local regulations during the course of the study and for at least 3 months following discontinuation of study drug (excluding women who are not of childbearing potential). Examples include the following: a) Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation b) Intrauterine device or intrauterine hormone-releasing system c) True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. A woman is considered of childbearing potential, following menarche and until becoming post-menopausal unless surgically sterile. Menopausal female patients must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential. Male patient who is sexually active with a woman of childbearing potential must agree to use highly effective method described as above or 2 acceptable methods of contraception (e.g., Male or female condom AND additional hormonal or barrier contraceptive method other than condom by female partner) consistent with local regulations during the course of the study and for at least 3 months following discontinuation of study drug. Contraception is not required if either patient or his/her partner who has been surgically sterilized more than 24 weeks prior to the date of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 253 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 107
Exclusion criteria
Exclusion criteria: A patient meeting any of the following criteria are not eligible for inclusion in this study: 1. Patient who has only one functional eye, even if the eye met all other study requirements, or has and/or is likely to have amblyopia, amaurosis or ocular disorder with BCVA 10% b) Uncontrolled blood pressure defined as systolic =160 mmHg or diastolic =100 mmHg measured after 5 minutes of rest while sitting c) History of vascular disease such as cerebrovascular accident, myocardial infarction, transient ischemic attack, or thromboembolic reaction including pulmonary embolism within 180 days prior to the first study drug administration d) New York Heart Association Functional Classification Class III or IV heart failure, or severe uncontrolled cardiac disease (i.e., unstable angina) e) Current treatment for serious systemic infection f) History of recurrent significant infections in the opinion of the investigator g) Renal failure requiring dialysis or renal transplant h) History of malignancies within 5 years prior to the first study drug administration, except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ i) History of other disease, metabolic dysfunction, physical examination finding, electrocardiogram (ECG) finding or clinical laboratory finding giving reasonable suspi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that CT-P42 is similar to Eylea in terms of efficacy as determined by clinical response according to the mean change from baseline at Week 8 in Best Corrected Visual Acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart;Secondary Objective: To evaluate additional efficacy, pharmacokinetics (PK), usability, and overall safety including immunogenicity;Primary end point(s): The primary efficacy endpoint is the mean change from baseline in BCVA using the ETDRS chart at Week 8.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary efficacy endpoints will be assessed at each applicable visit up to Week 52: - Mean change in BCVA using the ETDRS chart from baseline; - Proportion of patients who gained = 5, = 10, and = 15 ETDRS letters from baseline in BCVA using the ETDRS chart; - Proportion of patients who lost = 5, = 10, and = 15 ETDRS letters from baseline in BCVA using the ETDRS chart; - Mean change in central subfield thickness from baseline as determined by spectral domain optical coherence tomography (SD-OCT); - Percentage of patients with a = 2-step improvement from baseline in the ETDRS DRSS score as assessed by fundus photography (FP) The following secondary PK endpoints will be assessed: - Maximum plasma concentration after the first study drug administration (Cmax1); - Maximum plasma concentration after the fifth study drug administration (Cmax2); - Time of observed maximum plasma concentration after the first study drug administration (Tmax1); - Time of observed maximum plasma concentration after the fifth study drug administration (Tmax2); The following secondary usability endpoint will be assessed: - Number of injections with vial kit successfully administered by healthcare professionals at Week 0 The following secondary safety endpoints will be assessed: - Incidence and severity of AEs (ocular and non ocular) including SAEs; - Incidence and severity of adverse event of special interest (AESI); - Intraocular pressure test, slit lamp examination, indirect ophthalmoscopy, finger count/hand motion/light perception, hypersensitivity monitoring, vital signs and weight measurement, electrocardiogram (ECG), New York Heart Association (NYHA) Functional Classification assessment, physical examination findings, pregnancy testing, clinical laboratory analyses including hemoglobin A1c (HbA1c); - Immunogenicity, as assessed by incidence of anti-drug antibody and neutralizing antibody; - Prior and concomitant treatments ;Timepoint(s) of eval | — |
Countries
Czechia, Estonia, Germany, Hungary, India, Korea, Republic of, Latvia, Lithuania, Poland, Russian Federation, Slovakia, Spain, Ukraine
Contacts
Public ContactByeong Hyeon Kim
CELLTRION Inc.
Outcome results
None listed