A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Description

EYE-RES-103 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-103 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 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

Bakersfield

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

Modesto

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

Redlands

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

Sacramento

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

Santa Ana

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

Waterford

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

Deerfield Beach

Deerfield Beach, FL, Deerfield Beach, Florida, United States, 33064

Fort Lauderdale

Fort Lauderdale, FL, Fort Lauderdale, Florida, United States, 33308

Saint Petersburg

Saint Petersburg, FL, Saint Petersburg, Florida, United States, 33711

Lemont

Lemont, IL, Lemont, Illinois, United States, 60439

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 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

2028-06-30