A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
- Registration Number
- NCT06957080
- Lead Sponsor
- EyeBiotech Ltd.
- Brief Summary
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.
- Detailed 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).
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 960
Not provided
-
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 visual outcomes measured using the standardized ETDRS chart Duration of the study, through Week 104 Changes in visual outcomes measured using the standardized ETDRS chart
Changes in structural outcomes measured using OCT CST Duration of the study, through Week 104 Changes in structural outcomes measured using OCT CST
Trial Locations
- Locations (39)
Bakersfield, CA
🇺🇸Bakersfield, California, United States
Modesto, CA
🇺🇸Modesto, California, United States
Redlands, CA
🇺🇸Redlands, California, United States
Sacramento, CA
🇺🇸Sacramento, California, United States
Santa Ana
🇺🇸Santa Ana, California, United States
Waterford,CT
🇺🇸Waterford, Connecticut, United States
Deerfield Beach, FL
🇺🇸Deerfield Beach, Florida, United States
Fort Lauderdale, FL
🇺🇸Fort Lauderdale, Florida, United States
Saint Petersburg, FL
🇺🇸Saint Petersburg, Florida, United States
Lemont, IL
🇺🇸Lemont, Illinois, United States
Lenexa, KS
🇺🇸Lenexa, Kansas, United States
Hagerstown, MD
🇺🇸Hagerstown, Maryland, United States
Springfield,MA
🇺🇸Springfield, Massachusetts, United States
Edina, MN
🇺🇸Edina, Minnesota, United States
Madison, MS
🇺🇸Madison, Mississippi, United States
Bloomfield, NJ
🇺🇸Bloomfield, New Jersey, United States
Liverpool, NY
🇺🇸Liverpool, New York, United States
Rochester, NY
🇺🇸Rochester, New York, United States
Asheville, NC
🇺🇸Asheville, North Carolina, United States
Hickory, NC
🇺🇸Hickory, North Carolina, United States
Winston Salem, NC
🇺🇸Winston-Salem, North Carolina, United States
Erie, PA
🇺🇸Erie, Pennsylvania, United States
Beaufort, SC
🇺🇸Beaufort, South Carolina, United States
Florence, SC
🇺🇸Florence, South Carolina, United States
Ladson, SC
🇺🇸Ladson, South Carolina, United States
West Columbia, SC
🇺🇸West Columbia, South Carolina, United States
Germantown, TN
🇺🇸Germantown, Tennessee, United States
Abilene, TX
🇺🇸Abilene, Texas, United States
Amarillo, TX
🇺🇸Amarillo, Texas, United States
Arlington, TX
🇺🇸Arlington, Texas, United States
Austin, TX
🇺🇸Austin, Texas, United States
Bellaire, TX
🇺🇸Bellaire, Texas, United States
Dallas, TX
🇺🇸Dallas, Texas, United States
Katy, TX
🇺🇸Katy, Texas, United States
Plano, TX
🇺🇸Plano, Texas, United States
San Antonio, TX
🇺🇸San Antonio, Texas, United States
The Woodlands, TX
🇺🇸The Woodlands, Texas, United States
Willow Park, TX
🇺🇸Willow Park, Texas, United States
Lynchburg, VA
🇺🇸Lynchburg, Virginia, United States