Authorised Phase II and Phase III (Integrated) Diabetic Macular Edema

A randomized study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF

EU CTIS ID: 2025-520809-12-00

What this study is testing

The primary objective of the study is to demonstrate that EYE103 (0.5 mg or 0.8 mg) is non-inferior to ranibizumab 0.5 mg, as measured by the mean change in BCVA up to and including Week 52. This change will be measured using the standardized ETDRS 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

  • Participants must 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 (including those with <2 years since the onset of menopause, amenorrhea for <1 year, or not surgically sterile); such participants must agree to use a highly effective method of contraception from screening up to and including 3 months after the last dose of study drug (see Appendix B). She must also agree not to donate oocytes from screening up to and including 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 (see Appendix B). He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.

You likely can't join if

  • Be pregnant or breastfeeding.
  • Have aphakia in the study eye.
  • Have an allergy to fluorescein dye.
  • Have had vitrectomy in the study eye.
  • 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.
See the full eligibility criteria
Who can join
  • Participants must 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 (including those with <2 years since the onset of menopause, amenorrhea for <1 year, or not surgically sterile); such participants must agree to use a highly effective method of contraception from screening up to and including 3 months after the last dose of study drug (see Appendix B). She must also agree not to donate oocytes from screening up to and including 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 (see Appendix B). He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.
What rules you out
  • Be pregnant or breastfeeding.
  • Have aphakia in the study eye.
  • Have an allergy to fluorescein dye.
  • Have had vitrectomy in the study eye.
  • 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 prevent the participant from completing the required assessments for this study.
  • Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to mAbs.
  • Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or have renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study.
  • 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 If a participant’s initial reading exceeds these values, a second reading may be obtained later the same day or on another day during the screening period. If the participant’s blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Day 1.
  • Have history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening.
  • Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1.
  • Have any active malignancy.
  • Have any history of organ transplant.
  • If treatment-experienced for DME have a history of any of the following treatments within the noted time windows: • Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit • Had prior IVT investigational agents in either eye at any time • Had treatment with ocriplasmin (JETREA®) in the study eye at any time • Had previous use of ILUVIEN® at any time, of OZURDEX® IVT implants within 180 days of the Screening visit, or any other intraocular or periocular corticosteroids in the study eye within 90 days of the Screening visit
  • 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 or focal/grid thermal laser photocoagulation in the study eye within 90 days of screening.
  • 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 VA, assessment of safety, OCT, or fundus photography in the opinion of the reading center.
  • Have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Colombia
  • Brazil
  • United States
  • United Kingdom
  • Argentina
  • Turkey
  • Australia
  • Israel

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 Colombia; Brazil; United States; United Kingdom; Argentina; Turkey and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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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.