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

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) 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.

Conditions

Diabetic Macular Edema (DME)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diabetic Macular Edema (DME)
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Scottsdale, Scottsdale, Arizona, United States, 85255

Bakersfield

Bakersfield, CA, Bakersfield, California, United States, 93309

Modesto

Modesto, CA, Modesto, California, United States, 95356

Mountain View

Mountain View, CA, Mountain View, California, United States, 94040

Redlands

Redlands, CA, Redlands, California, United States, 92374

Sacramento

Sacramento, CA, Sacramento, California, United States, 95825

Sacramento

Sacramento, CA, Sacramento, California, United States, 95841

Santa Ana

Santa Ana, Santa Ana, California, United States, 92705

Colorado Springs

Colorado Springs, CO, Colorado Springs, Colorado, United States, 80909

Waterford

Waterford,CT, Waterford, Connecticut, United States, 06385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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.
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EyeBiotech Ltd.,

Charles Miller, MD PhD, STUDY_DIRECTOR, EyeBiotech Ltd.

Study Record Dates

2027-12-31