A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Phase 2

Active, not recruiting

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: EYE103; Drug: Ranibizumab

• Registration Number: NCT06571045
• Lead Sponsor: EyeBiotech Ltd.

Brief Summary

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.

Approximately 960 participants will be entered in the study.

Detailed Description

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Study Timeline

• Study Start: 2024-08-07
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Status Verified: 2024-10
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-12
• Primary Completion: 2026-09
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 984

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EYE103 Low Dose Treatment Arm	EYE103	EYE103 Low Dose Treatment Arm
EYE103 High Dose Treatment Arm	EYE103	EYE103 High Dose Treatment Arm
Ranibizumab Treatment Arm	Ranibizumab	Ranibizumab Treatment Arm

Primary Outcome Measures

Name	Time	Method
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart	52 Weeks	Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart

Secondary Outcome Measures

Name	Time	Method
Changes in structural and visual outcomes	Duration of the study, through Week 104	Changes in structural and visual outcomes

Trial Locations

Locations (158)

Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Fayetteville, Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

Springdale, Arkansas; 🇺🇸 Springdale, Arkansas, United States

Bakersfield, CA; 🇺🇸 Bakersfield, California, United States

Glendale, CA; 🇺🇸 Glendale, California, United States

Modesto, CA; 🇺🇸 Modesto, California, United States

Mountain View, CA; 🇺🇸 Mountain View, California, United States

Redlands, CA; 🇺🇸 Redlands, California, United States

Sacramento, CA; 🇺🇸 Sacramento, California, United States

Santa Ana; 🇺🇸 Santa Ana, California, United States

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