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A randomized study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF (in patients with Diabetic Macular Edema)
EU CTIS ID: 2024-510944-30-00
What this study is testing
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).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 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 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
See the full eligibility criteria
- 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
- 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 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 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 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 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 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 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 history of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) in the study eye within 90 days of Screening.
- Have any treatment for complications of cataract surgery with steroids or Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 90 days of Screening.
- 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 any active malignancy
- Have any history of organ transplant
- 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 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 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 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 aphakia in the study eye.
- Have allergy to fluorescein dye.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- Argentina
- Colombia
- United States
- Turkey
- Brazil
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; Argentina; Colombia; United States; Turkey and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.