A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison with Eylea in Patients with Diabetic Macular Edema

CELLTRION Inc.0 sites360 target enrollmentStarted: December 1, 2020Last updated: March 2, 2022

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: CELLTRION Inc.
Enrollment: 360

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

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

•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 < 34 ETDRS letter score (approximate Snellen equivalent of < 20/200) in the fellow eye
•2. Patient who currently has, or has a history (where indicated) of ocular condition including one or more of the following in the study eye:
•a) Active proliferative diabetic retinopathy, or pre-retinal fibrosis involving the macula
•c) Vitreomacular traction or epiretinal membrane that is expected to affect central vision
•d) Iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
•e) Ocular inflammation (including trace or above)
•f) Uncontrolled glaucoma or filtration surgery for glaucoma in the past or likely to be needed in the future
•g) Intraocular pressure (IOP) =25 mmHg
•h) Spherical equivalent of the refractive error of more than -6 diopters myopia
•i) Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
•j) Concurrent and/or history of disease, other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) as assessed by the investigator
•k) Inability to obtain fundus and OCT images due to, but not limited to, insufficient media clarity or inadequate pupil dilation
•3. Patient who currently has, or has a history (where indicated) of ocular condition including one or more of the following in either eye:
•a) Concurrent and/or history of idiopathic or autoimmune uveitis
•b) Evidence or suspicion of infection including blepharitis, keratitis, scleritis, or conjunctivitis.
•However, a patient who has completely recovered from the infection at Day 1 is allowed to be enrolled at the investigator’s discretion.
•4. Patient who currently has, or has a history of (where indicated) systemic condition including one or more of the following:
•a) Uncontrolled DM as defined by hemoglobin A1c >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 susp

Investigators

Sponsor

CELLTRION Inc.

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