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Evaluating EYE103 for Diabetic Macular Edema

A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal 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

Phase2; Phase3 Interventional EyeBiotech Ltd. · NCT06571045

This study is testing whether two different doses of a new eye treatment called EYE103 can help people with diabetic macular edema feel better compared to a standard treatment.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment960 (estimated)
Ages18 Years and up
SexAll
SponsorEyeBiotech Ltd. Industry-sponsored
Drugs / interventionsfaricimab, ranibizumab, bevacizumab, brolucizumab
Locations177 sites (Scottsdale, Arizona and 176 other locations)
Trial IDNCT06571045 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of two doses of EYE103 compared to ranibizumab in patients with diabetic macular edema (DME). Approximately 960 participants will be randomized to receive either low dose EYE103, high dose EYE103, or 0.5 mg ranibizumab via intravitreal injection. Treatment will occur every four weeks during the first year, with a personalized treatment interval algorithm implemented in the second year. Participants will undergo regular evaluations, including visual acuity and imaging assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 1 or type 2 diabetes and vision loss primarily due to DME.

Not a fit: Patients who are pregnant, breastfeeding, or have recent eye surgeries or treatments that could interfere with the study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with diabetic macular edema, potentially improving vision outcomes.

How similar studies have performed: Other studies have shown success with similar approaches in treating diabetic macular edema, indicating potential for this study's success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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.
* Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%.
* Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

Exclusion Criteria:

* Be pregnant or breastfeeding
* History of cataract surgery and/or minimally invasive glaucoma surgery 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
* Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
* 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

Where this trial is running

Scottsdale, Arizona and 176 other locations

+127 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular EdemaDME
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.