A randomized study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF (in patients with Diabetic Macular Edema)

Trial details

Who runs it

Eyebiotech Limited

Trial code

EU 2024-510944-30-00

Record updated

2026. június 12.

Original description

The primary objective of the study is to demonstrate non-inferiority of EYE103 (0.5 mg or 0.8 mg) to anti-VEGF 0.5 mg, as measured by mean change in best-corrected visual acuity (BCVA) up to and including Week 52. This change will be measured using the standardized ETDRS (Early Treatment of Diabetic Retinopathy Study) chart from Day 1 to Year 1 (average of Weeks 48 and 52).Read full original descriptionShow less

A RANDOMIZED, DOUBLE-MASKED, MULTI-CENTER, 3-ARM PHASE 2/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVITREAL EYE103 COMPARED WITH INTRAVITREAL RANIBIZUMAB (0.5MG) IN PARTICIPANTS WITH DIABETIC MACULAR EDEMA

The primary objective of the study is to demonstrate non-inferiority of EYE103 (0.5 mg or 0.8 mg) to anti-VEGF 0.5 mg, as measured by mean change in best-corrected visual acuity (BCVA) up to and including Week 52. This change will be measured using the standardized ETDRS (Early Treatment of Diabetic Retinopathy Study) chart from Day 1 to Year 1 (average of Weeks 48 and 52).

Inclusion: Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity; Be male or female ≥ 18 years of age; If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential (defined as any female who has begun menstruation and who is not permanently sterile, and is not postmenopausal [defined as a female who has not had a menstrual period for at least 12 months without an alternative medical cause]); such participants must agree to use an acceptable method of contraception for 3 months after the last dose of study drug; If male, be surgically sterile for at least 12 weeks, or agree to use an acceptable method of contraception, such as a condom, and a second highly effective method of contraception (see Appendix F) from Screening up to and including 90 days after the last dose of study drug.

Exclusion: Have any history or evidence of a concurrent ocular condition present in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study; Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to monoclonal antibodies (mAbs); Have previously participated in any study of EYE103; Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1; Are currently using of drugs with known retinal toxicity; Have any treatment for complications of cataract surgery with steroids or Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 90 days of Screening; Any ilicit drug use in the past 1 year; Had prior IVT complement inhibitors in either eye at any time; Have had glaucoma-filtering surgery (trabeculectomy or tube shunt) in the study eye; Have a cataract in the study eye that in the judgment of the Investigator is expected to require surgical extraction within 4 months of Screening; Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis at any time during the study; Have active retinal disease other than the condition (DME/diabetic retinopathy) under investigation in the study eye; Have active or suspected ocular or periocular infection or inflammation in either eye at Day 1; Currently have evidence of, or a history of any clinically significant autoimmune, cardiovascular, hematologic, hepatic, metabolic, peripheral vascular, renal, or respiratory disease, which, in the opinion of the Investigator, would exclude the participant from this study; Have history of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) in the study eye within 90 days of Screening; Have any active malignancy; Have any history of organ transplant; Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye; Have any history of uveitis in either eye; Have allergy to fluorescein dye; Participants must not: Be pregnant or breastfeeding; Have had vitrectomy in the study eye; Have known or former myopia with a spherical equivalent of >8 diopters; Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest; Have advanced or uncontrolled glaucoma in the study eye; Have had Pan-retinal Photocoagulation (PRP) or focal/grid thermal laser photocoagulation in the study eye within 90 days of Screening; Have tractional retinal detachment in the study eye; Have significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, OCT, or fundus photography in the opinion of the reading center; Have aphakia in the study eye.

EU CTIS 2024-510944-30-00