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

NCT06571045

Active Not RecruitingPhase 2, Phase 3

Sponsor: EyeBiotech Ltd.

Conditions: Diabetic Macular Edema (DME)

Interventions: Ranibizumab, EYE103

Countries: United States, Argentina, Australia, Austria, Colombia, Croatia, Czechia, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 hemoglobin A1c (HbA1c) of ≤12%.
* Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (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 in the study eye 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
Locations (183)
  • Scottsdale, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Springdale, Arkansas, United States
  • Bakersfield, California, United States
  • Glendale, California, United States
  • Modesto, California, United States
  • Mountain View, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Santa Ana, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Danbury, Connecticut, United States
  • Manchester, Connecticut, United States
  • Waterford, Connecticut, United States
  • Deerfield Beach, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Fort Myers, Florida, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Plantation, Florida, United States
  • Sarasota, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Winter Haven, Florida, United States
  • Lemont, Illinois, United States
  • Springfield, Illinois, United States
  • + 153 more on CT.gov