Clinical trial NCT06571045: A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema (DME)
Keywords: Diabetic Macular Edema
DME
Lead sponsor: EyeBiotech Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel enrollment into 1 of 3 arms
Primary purpose: TREATMENT

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.

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 HbA1c of ≤12%.
* Have a decrease in vision in the study eye determined by the investigator to be primarily the result of 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 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

Primary outcomes:
measure: Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
timeFrame: 52 Weeks
Secondary outcomes:
measure: Changes in structural and visual outcomes
timeFrame: Duration of the study, through Week 104
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale
state: Arizona
city: Fayetteville
country: United States
facility: Fayetteville, Arkansas
state: Arkansas
city: Springdale
country: United States
facility: Springdale, Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield, CA
state: California
city: Glendale
country: United States
facility: Glendale, CA
state: California
city: Modesto
country: United States
facility: Modesto, CA
state: California
city: Mountain View
country: United States
facility: Mountain View, CA
state: California
city: Redlands
country: United States
facility: Redlands, CA
state: California
city: Sacramento
country: United States
facility: Sacramento, CA
state: California
city: Sacramento
country: United States
facility: Sacramento, CA
state: California
city: Santa Ana
country: United States
facility: Santa Ana
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs, CO
state: Colorado
city: Denver
country: United States
facility: Denver, Colorado
state: Colorado
city: Danbury
country: United States
facility: Danbury, CT
state: Connecticut
city: Manchester
country: United States
facility: Manchester, CT
state: Connecticut
city: Waterford
country: United States
facility: Waterford,CT
state: Connecticut
city: Deerfield Beach
country: United States
facility: Deerfield Beach, FL
state: Florida
city: Fort Lauderdale
country: United States
facility: Fort Lauderdale, FL
state: Florida
city: Fort Myers
country: United States
facility: Fort Myers,FL
state: Florida
city: Gainesville
country: United States
facility: Gainesville, FL
state: Florida
city: Orlando
country: United States
facility: Orlando, Florida
state: Florida
city: Plantation
country: United States
facility: Plantation, FL
state: Florida
city: Saint Petersburg
country: United States
facility: Saint Petersburg, FL
state: Florida
city: Sarasota
country: United States
facility: Sarasota, FL
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee, FL
state: Florida
city: Tampa
country: United States
facility: Tampa, FL
state: Florida
city: Tampa
country: United States
facility: Tampa, FL
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven, FL
state: Florida
city: Lemont
country: United States
facility: Lemont, IL
state: Illinois
city: Springfield
country: United States
facility: Springfield, Illinois
state: Illinois
city: West Des Moines
country: United States
facility: West Des Moines, IA
state: Iowa
city: Lenexa
country: United States
facility: Lenexa, Kansas
state: Kansas
city: Wichita
country: United States
facility: Wichita, Kansas
state: Kansas
city: Portland
country: United States
facility: Portland, Maine
state: Maine
city: Hagerstown
country: United States
facility: Hagerstown, MD
state: Maryland
city: Springfield
country: United States
facility: Springfield,MA
state: Massachusetts
city: Grand Rapids
country: United States
facility: Grand Rapids, Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis, MN
state: Minnesota
city: Madison
country: United States
facility: Madison, MS
state: Mississippi
city: Bloomfield
country: United States
facility: Bloomfield, NJ
state: New Jersey
city: Cherry Hill
country: United States
facility: Cherry Hill, NJ
state: New Jersey
city: Liverpool
country: United States
facility: Liverpool, NY
state: New York
city: Oceanside
country: United States
facility: Oceanside, NY
state: New York
city: Rochester
country: United States
facility: Rochester, NY
state: New York
city: Asheville
country: United States
facility: Asheville, NC
state: North Carolina
city: Hickory
country: United States
facility: Hickory, NC
state: North Carolina
city: Wake Forest
country: United States
facility: Wake Forest, MC
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston Salem, NC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland, Ohio
state: Ohio
city: Cleveland
country: United States
facility: Cleveland, OH
state: Ohio
city: Youngstown
country: United States
facility: Youngstown, Ohio
state: Ohio
city: Edmond
country: United States
facility: Edmond, OK
state: Oklahoma
city: Portland
country: United States
facility: Portland, OR
state: Oregon
city: Springfield
country: United States
facility: Springfield, Oregon
state: Oregon
city: Bethlehem
country: United States
facility: Bethlehem, PA
state: Pennsylvania
city: Erie
country: United States
facility: Erie, PA
state: Pennsylvania
city: Beaufort
country: United States
facility: Beaufort, SC
state: South Carolina
city: Florence
country: United States
facility: Florence, SC
state: South Carolina
city: Ladson
country: United States
facility: Ladson, SC
state: South Carolina
city: West Columbia
country: United States
facility: West Columbia, SC
state: South Carolina
city: Germantown
country: United States
facility: Germantown, TN
state: Tennessee
city: Hixson
country: United States
facility: Hixson, Tennessee
state: Tennessee
city: Johnson City
country: United States
facility: Johnson City, Tennessee
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville, TN
state: Tennessee
city: Nashville
country: United States
facility: Nashville, TN
state: Tennessee
city: Abilene
country: United States
facility: Abilene, TX
state: Texas
city: Amarillo
country: United States
facility: Amarillo, TX
state: Texas
city: Amarillo
country: United States
facility: Amarillo, TX
state: Texas
city: Arlington
country: United States
facility: Arlington, TX
state: Texas
city: Austin
country: United States
facility: Austin, TX
state: Texas
city: Beaumont
country: United States
facility: Beaumont, TX
state: Texas
city: Bellaire
country: United States
facility: Bellaire, TX
state: Texas
city: Dallas
country: United States
facility: Dallas, TX
state: Texas
city: Fort Worth
country: United States
facility: Fort Worth, TX
state: Texas
city: Katy
country: United States
facility: Katy, TX
state: Texas
city: Plano
country: United States
facility: Plano, TX
state: Texas
city: Round Rock
country: United States
facility: Round Rock, TX
state: Texas
city: San Antonio
country: United States
facility: San Antonio, TX
state: Texas
city: Schertz
country: United States
facility: Schertz, Texas
state: Texas
city: The Woodlands
country: United States
facility: The Woodlands, TX
state: Texas
city: Willow Park
country: United States
facility: Willow Park, TX
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake City, Utah
state: Utah
city: Lynchburg
country: United States
facility: Lynchburg, VA
state: Virginia
city: Richmond
country: United States
facility: Richmond, Virginia
state: Virginia
city: Spokane
country: United States
facility: Spokane, WA
state: Washington
city: Caba
country: Argentina
facility: Buenos Aires, Argentina
state: Buenos Aires
city: Caba
country: Argentina
facility: Buenos Aires, Argentina
state: Buenos Aires
city: Caba
country: Argentina
facility: Buenos Aires, Argentina
state: Buenos Aires
city: Caba
country: Argentina
facility: Caba, Buenos Aires, Argentina
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Cordoba, Argentina
state: Cordoba
city: Rosario
country: Argentina
facility: Santa Fe, Argentina
state: Santa Fe
city: Rosario
country: Argentina
facility: Santa Fe, Argentina
state: Sante Fe
city: Caba
country: Argentina
facility: Buenos Aires, Argentina
city: Ciudad de Cordoba
country: Argentina
facility: Ciudad de Cordoba, Argentina
city: Sydney
country: Australia
facility: Sydney Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney, Australia
state: New South Wales
city: Albury
country: Australia
facility: Albury, Australia
city: Parramatta
country: Australia
facility: Parramatta, Australia
city: Sydney
country: Australia
facility: Sydney, Australia
city: Graz
country: Austria
facility: Graz, Austria
city: Innsbruck
country: Austria
facility: Innsbruck, Austria
city: Vienna
country: Austria
facility: Vienna, Austria
city: Vienna
country: Austria
facility: Vienna, Austria
city: Medellín
country: Colombia
facility: Medellin, Colombia
state: Antioquia
city: Barranquilla
country: Colombia
facility: Barranquilla, Colombia
state: Atlantico
city: Bogotá
country: Colombia
facility: Bogota, Columbia
state: Columbia
city: Cali
country: Colombia
facility: Cali, Colombia
state: Valle Del Cauca
city: Medellín
country: Colombia
facility: Medellin, Colombia
city: Osijek
country: Croatia
facility: Osijek, Croatia
city: Mladá Boleslav
country: Czechia
facility: Mlada Boleslav, Czechia
city: Náchod
country: Czechia
facility: Nachod, Czechia
city: Prague
country: Czechia
facility: Prague, Czechia
city: Prague
country: Czechia
facility: Prague, Czechia
city: Dijon
country: France
facility: Cedex, France
state: Cedex
city: Créteil
country: France
facility: Creteil, France
city: Lyon
country: France
facility: Lyon, France
city: Marseille
country: France
facility: Marseille, France
city: Paris
country: France
facility: Paris, France
city: Paris
country: France
facility: Paris, France
city: Paris
country: France
facility: Paris, France
city: Saint-Cyr-sur-Loire
country: France
facility: Saint Cyr sur Loire, France
city: Frankfurt
country: Germany
facility: Frankfurt, Germany
city: Münster
country: Germany
facility: Munster, Germany
city: Budapest
country: Hungary
facility: Budapest, Hungary
city: Budapest
country: Hungary
facility: Budapest, Hungary
city: Budapest
country: Hungary
facility: Budapest, Hungry
city: Debrecen
country: Hungary
facility: Debrecen, Hungary
city: Pecs
country: Hungary
facility: Pecs, Hungary
city: Szeged
country: Hungary
facility: Szeged, Hungary
city: Be'er Ya'aqov
country: Israel
facility: Beer Yakov, Israel
city: Haifa
country: Israel
facility: Haifa, Israel
city: Jerusalem
country: Israel
facility: Jerusalem, Israel
city: Petah tikva
country: Israel
facility: Petah Tikva, Israel
city: Reẖovot
country: Israel
facility: Rehovot, Israel
city: Tel Aviv
country: Israel
facility: Tel Aviv, Israel
city: Firenze
country: Italy
facility: Firenze, Italy
city: Milano
country: Italy
facility: Milano, Italy
city: Milano
country: Italy
facility: Milano, Italy
city: Milano
country: Italy
facility: Milano, Italy
city: Roma
country: Italy
facility: Roma, Italy
city: Rome
country: Italy
facility: Rome, Italy
city: Udine
country: Italy
facility: Udine, Italy
city: Riga
country: Latvia
facility: Riga, Latvia
city: Riga
country: Latvia
facility: Riga, Latvia
city: Gdańsk
country: Poland
facility: Gdansk, Poland
state: Gdansk
city: Białystok
country: Poland
facility: Bialystok, Poland
city: Bydgoszcz
country: Poland
facility: Bydgoszcz, Poland
city: Bydgoszcz
country: Poland
facility: Bydgoszcz, Poland
city: Gdańsk
country: Poland
facility: Gdansk, Poland
city: Katowice
country: Poland
facility: Katowice, Poland
city: Kraków
country: Poland
facility: Krakow, Poland
city: Olsztyn
country: Poland
facility: Olsztyn, Poland
city: Tarnowskie Góry
country: Poland
facility: Tarnowskie Gory, Poland
city: Coimbra
country: Portugal
facility: Coimbra, Portugal
city: Coimbra
country: Portugal
facility: Coimbra, Portugal
city: Porto
country: Portugal
facility: Porto, Portugal
city: Arecibo
country: Puerto Rico
facility: Arecibo, PR
city: Trebišov
country: Slovakia
facility: Trebisov, Slovakia
city: Trenčín
country: Slovakia
facility: Trencin, Slovakia
city: Žilina
country: Slovakia
facility: Zilina, Slovakia
city: Burjassot
country: Spain
facility: Valencia, Spain
state: Valencia
city: Barcelona
country: Spain
facility: Barcelona, Spain
city: Barcelona
country: Spain
facility: Barcelona, Spain
city: Barcelona
country: Spain
facility: Barcelona, Spain
city: Barcelona
country: Spain
facility: Barcelona, Spain
city: Santiago De Compostela
country: Spain
facility: Santiago de Compostela, Spain
city: Sevilla
country: Spain
facility: Sevilla, Spain
city: Zaragoza
country: Spain
facility: Zaragoza, Spain
city: Ankara
country: Turkey
facility: Ankara, Turkey
city: Ankara
country: Turkey
facility: Ankara, Turkey
city: London
country: United Kingdom
facility: London, UK
state: Middlesex
city: York
country: United Kingdom
facility: York, United Kingdom
state: UnitedKingdom
city: Bradford
country: United Kingdom
facility: Bradford, United Kingdom
city: Bristol
country: United Kingdom
facility: Bristol, UK
city: Liverpool
country: United Kingdom
facility: Liverpool, United Kingdom
city: Sunderland
country: United Kingdom
facility: Sunderland, United Kingdom
city: Wolverhampton
country: United Kingdom
facility: Wolverhamptom, United Kingdom
Study officials:
affiliation: EyeBiotech Ltd.
name: Charles Miller, MD PhD
role: STUDY_DIRECTOR
References: