A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 960
- 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
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 (153)
Zilina, Slovakia
🇸🇰Žilina, Slovakia
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
Denver, Colorado
🇺🇸Denver, Colorado, United States
Santa Ana
🇺🇸Santa Ana, California, United States
Colorado Springs, CO
🇺🇸Colorado Springs, Colorado, United States
Danbury, CT
🇺🇸Danbury, Connecticut, United States
Manchester, CT
🇺🇸Manchester, Connecticut, United States
Waterford,CT
🇺🇸Waterford, Connecticut, United States
Deerfield Beach, FL
🇺🇸Deerfield Beach, Florida, United States
Fort Lauderdale, FL
🇺🇸Fort Lauderdale, Florida, United States
Fort Myers,FL
🇺🇸Fort Myers, Florida, United States
Gainesville, FL
🇺🇸Gainesville, Florida, United States
Orlando, Florida
🇺🇸Orlando, Florida, United States
Plantation, FL
🇺🇸Plantation, Florida, United States
Saint Petersburg, FL
🇺🇸Saint Petersburg, Florida, United States
Debrecen, Hungary
🇭🇺Debrecen, Hungary
Sarasota, FL
🇺🇸Sarasota, Florida, United States
Tallahassee, FL
🇺🇸Tallahassee, Florida, United States
Tampa, FL
🇺🇸Tampa, Florida, United States
Winter Haven, FL
🇺🇸Winter Haven, Florida, United States
Lemont, IL
🇺🇸Lemont, Illinois, United States
Springfield, Illinois
🇺🇸Springfield, Illinois, United States
West Des Moines, IA
🇺🇸West Des Moines, Iowa, United States
Lenexa, Kansas
🇺🇸Lenexa, Kansas, United States
Wichita, Kansas
🇺🇸Wichita, Kansas, United States
Portland, Maine
🇺🇸Portland, Maine, United States
Hagerstown, MD
🇺🇸Hagerstown, Maryland, United States
Springfield,MA
🇺🇸Springfield, Massachusetts, United States
Grand Rapids, Michigan
🇺🇸Grand Rapids, Michigan, United States
Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Madison, MS
🇺🇸Madison, Mississippi, United States
Bloomfield, NJ
🇺🇸Bloomfield, New Jersey, United States
Cherry Hill, NJ
🇺🇸Cherry Hill, New Jersey, United States
Liverpool, NY
🇺🇸Liverpool, New York, United States
Oceanside, NY
🇺🇸Oceanside, 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
Wake Forest, MC
🇺🇸Wake Forest, North Carolina, United States
Winston Salem, NC
🇺🇸Winston-Salem, North Carolina, United States
Cleveland, Ohio
🇺🇸Cleveland, Ohio, United States
Cleveland, OH
🇺🇸Cleveland, Ohio, United States
Youngstown, Ohio
🇺🇸Youngstown, Ohio, United States
Edmond, OK
🇺🇸Edmond, Oklahoma, United States
Portland, OR
🇺🇸Portland, Oregon, United States
Springfield, Oregon
🇺🇸Springfield, Oregon, United States
Bethlehem, PA
🇺🇸Bethlehem, Pennsylvania, 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
Hixson, Tennessee
🇺🇸Hixson, Tennessee, United States
Johnson City, Tennessee
🇺🇸Johnson City, Tennessee, United States
Knoxville, TN
🇺🇸Knoxville, Tennessee, United States
Nashville, TN
🇺🇸Nashville, 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
Beaumont, TX
🇺🇸Beaumont, Texas, United States
Bellaire, TX
🇺🇸Bellaire, Texas, United States
Dallas, TX
🇺🇸Dallas, Texas, United States
Fort Worth, TX
🇺🇸Fort Worth, Texas, United States
Plano, TX
🇺🇸Plano, Texas, United States
Schertz, Texas
🇺🇸Schertz, Texas, United States
Katy, TX
🇺🇸Katy, Texas, United States
Round Rock, TX
🇺🇸Round Rock, 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
Salt Lake City, Utah
🇺🇸Salt Lake City, Utah, United States
Lynchburg, VA
🇺🇸Lynchburg, Virginia, United States
Richmond, Virginia
🇺🇸Richmond, Virginia, United States
Spokane, WA
🇺🇸Spokane, Washington, United States
Buenos Aires, Argentina
🇦🇷Caba, Argentina
Caba, Buenos Aires, Argentina
🇦🇷Caba, Buenos Aires, Argentina
Cordoba, Argentina
🇦🇷Córdoba, Cordoba, Argentina
Santa Fe, Argentina
🇦🇷Rosario, Sante Fe, Argentina
Ciudad de Cordoba, Argentina
🇦🇷Ciudad de Cordoba, Argentina
Sydney Retina Clinic
🇦🇺Sydney, New South Wales, Australia
Sydney, Australia
🇦🇺Sydney, Australia
Albury, Australia
🇦🇺Albury, Australia
Trencin, Slovakia
🇸🇰Trenčín, Slovakia
Parramatta, Australia
🇦🇺Parramatta, Australia
Graz, Austria
🇦🇹Graz, Austria
Innsbruck, Austria
🇦🇹Innsbruck, Austria
Vienna, Austria
🇦🇹Vienna, Austria
Medellin, Colombia
🇨🇴Medellín, Colombia
Barranquilla, Colombia
🇨🇴Barranquilla, Atlantico, Colombia
Bogota, Columbia
🇨🇴Bogotá, Columbia, Colombia
Cali, Colombia
🇨🇴Cali, Valle Del Cauca, Colombia
Osijek, Croatia
🇭🇷Osijek, Croatia
Mlada Boleslav, Czechia
🇨🇿Mladá Boleslav, Czechia
Nachod, Czechia
🇨🇿Náchod, Czechia
Prague, Czechia
🇨🇿Prague, Czechia
Cedex, France
🇫🇷Dijon, Cedex, France
Creteil, France
🇫🇷Créteil, France
Lyon, France
🇫🇷Lyon, France
Marseille, France
🇫🇷Marseille, France
Paris, France
🇫🇷Paris, France
Saint Cyr sur Loire, France
🇫🇷Saint-Cyr-sur-Loire, France
Frankfurt, Germany
🇩🇪Frankfurt, Germany
Munster, Germany
🇩🇪Münster, Germany
Budapest, Hungary
🇭🇺Budapest, Hungary
Budapest, Hungry
🇭🇺Budapest, Hungary
Pecs, Hungary
🇭🇺Pecs, Hungary
Szeged, Hungary
🇭🇺Szeged, Hungary
Beer Yakov, Israel
🇮🇱Be'er Ya'aqov, Israel
Haifa, Israel
🇮🇱Haifa, Israel
Jerusalem, Israel
🇮🇱Jerusalem, Israel
Petah Tikva, Israel
🇮🇱Petah tikva, Israel
Rehovot, Israel
🇮🇱Reẖovot, Israel
Tel Aviv, Israel
🇮🇱Tel Aviv, Israel
Firenze, Italy
🇮🇹Firenze, Italy
Milano, Italy
🇮🇹Milano, Italy
Roma, Italy
🇮🇹Roma, Italy
Rome, Italy
🇮🇹Rome, Italy
Udine, Italy
🇮🇹Udine, Italy
Riga, Latvia
🇱🇻Riga, Latvia
Gdansk, Poland
🇵🇱Gdańsk, Poland
Bialystok, Poland
🇵🇱Białystok, Poland
Bydgoszcz, Poland
🇵🇱Bydgoszcz, Poland
Katowice, Poland
🇵🇱Katowice, Poland
Krakow, Poland
🇵🇱Kraków, Poland
Olsztyn, Poland
🇵🇱Olsztyn, Poland
Tarnowskie Gory, Poland
🇵🇱Tarnowskie Góry, Poland
Coimbra, Portugal
🇵🇹Coimbra, Portugal
Porto, Portugal
🇵🇹Porto, Portugal
Arecibo, PR
🇵🇷Arecibo, Puerto Rico
Trebisov, Slovakia
🇸🇰Trebišov, Slovakia
Valencia, Spain
🇪🇸Burjassot, Valencia, Spain
Barcelona, Spain
🇪🇸Barcelona, Spain
Santiago de Compostela, Spain
🇪🇸Santiago De Compostela, Spain
Sevilla, Spain
🇪🇸Sevilla, Spain
Zaragoza, Spain
🇪🇸Zaragoza, Spain
Ankara, Turkey
🇹🇷Ankara, Turkey
London, UK
🇬🇧London, Middlesex, United Kingdom
York, United Kingdom
🇬🇧York, UnitedKingdom, United Kingdom
Bradford, United Kingdom
🇬🇧Bradford, United Kingdom
Bristol, UK
🇬🇧Bristol, United Kingdom
Liverpool, United Kingdom
🇬🇧Liverpool, United Kingdom
Sunderland, United Kingdom
🇬🇧Sunderland, United Kingdom
Wolverhamptom, United Kingdom
🇬🇧Wolverhampton, United Kingdom