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

Status: Recruiting
Location: See all (130) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Fayetteville, AR
RECRUITING
Fayetteville
Arizona
Gilbert, Arizona
RECRUITING
Gilbert
Phoenix, Arizona
RECRUITING
Phoenix
Scottsdale, AZ
RECRUITING
Scottsdale
California
Bakersfield, CA
RECRUITING
Bakersfield
Encino, California
RECRUITING
Encino
Modesto, CA
RECRUITING
Modesto
Mountain View, CA
RECRUITING
Mountain View
Redlands, CA
RECRUITING
Redlands
Sacramento, CA
RECRUITING
Sacramento
Sacramento, CA
RECRUITING
Sacramento
Santa Ana
RECRUITING
Santa Ana
Santa Ana, CA
RECRUITING
Santa Ana
Colorado
Colorado Springs, CO
RECRUITING
Colorado Springs
Denver, CO
RECRUITING
Denver
Durango, CO
RECRUITING
Durango
Connecticut
Danbury, CT
RECRUITING
Danbury
Manchester, CT
RECRUITING
Manchester
Waterford, CT
RECRUITING
Waterford
Waterford,CT
RECRUITING
Waterford
Florida
Deerfield Beach, FL
RECRUITING
Deerfield Beach
Fort Lauderdale, FL
RECRUITING
Fort Lauderdale
Fort Myers, FL
RECRUITING
Fort Myers
Gainesville, FL
RECRUITING
Gainesville
Orlando, FL
RECRUITING
Orlando
Plantation, FL
RECRUITING
Plantation
Sarasota, FL
RECRUITING
Sarasota
Saint Petersburg, FL
RECRUITING
St. Petersburg
Tallahassee, FL
RECRUITING
Tallahassee
Tampa, FL
RECRUITING
Tampa
Tampa, FL
RECRUITING
Tampa
Winter Haven, FL
RECRUITING
Winter Haven
Iowa
West Des Moines, IA
RECRUITING
West Des Moines
Illinois
Lemont, IL
RECRUITING
Lemont
Oak Park, IL
RECRUITING
Oak Park
Springfield, IL
RECRUITING
Springfield
Kansas
Lenexa, KS
RECRUITING
Lenexa
Wichita, Kansas
RECRUITING
Wichita
Massachusetts
Springfield,MA
RECRUITING
Springfield
Maryland
Baltimore, Maryland
RECRUITING
Baltimore
Hagerstown, MD
RECRUITING
Hagerstown
Towson, MD
RECRUITING
Towson
Maine
Portland, ME
RECRUITING
Portland
Michigan
Grand Rapids, MI
RECRUITING
Grand Rapids
Minnesota
Edina, MN
RECRUITING
Edina
Minneapolis, MN
RECRUITING
Minneapolis
Mississippi
Madison, MS
RECRUITING
Madison
North Carolina
Asheville, NC
RECRUITING
Asheville
Cary, North Carolina
RECRUITING
Cary
Hickory, NC
RECRUITING
Hickory
Wake Forest, NC
RECRUITING
Wake Forest
Winston Salem, NC
RECRUITING
Winston-salem
Winston-Salem, NC
RECRUITING
Winston-salem
New Jersey
Bloomfield, NJ
RECRUITING
Bloomfield
Cherry Hill, NJ
RECRUITING
Cherry Hill
New York
Great Neck, New York
RECRUITING
Great Neck
Hauppauge, New York
RECRUITING
Hauppauge
Liverpool, NY
RECRUITING
Liverpool
Rochester, NY
RECRUITING
Rochester
Oklahoma
Tulsa, Oklahoma
RECRUITING
Tulsa
Oregon
Portland, OR
RECRUITING
Portland
Salem, Oregon
RECRUITING
Salem
Springfield, OR
RECRUITING
Springfield
Pennsylvania
Bethlehem, PA
RECRUITING
Bethlehem
Erie, PA
RECRUITING
Erie
South Carolina
Aiken, SC
RECRUITING
Aiken
Beaufort, NC
RECRUITING
Beaufort
Beaufort, SC
RECRUITING
Beaufort
Charleston, SC
RECRUITING
Charleston
Florence, SC
RECRUITING
Florence
Ladson, NC
RECRUITING
Ladson
Ladson, SC
RECRUITING
Ladson
West Columbia, SC
RECRUITING
West Columbia
Tennessee
Germantown, TN
RECRUITING
Germantown
Hixson, TN
RECRUITING
Hixson
Johnson City, TN
RECRUITING
Johnson City
Knoxville, TN
RECRUITING
Knoxville
Nashville, TN
RECRUITING
Nashville
Texas
Abilene, TX
RECRUITING
Abilene
Amarillo, TX
RECRUITING
Amarillo
Arlington, TX
RECRUITING
Arlington
Austin, TX
RECRUITING
Austin
Bellaire, TX
RECRUITING
Bellaire
Burleson, Texas
RECRUITING
Burleson
Dallas, TX
RECRUITING
Dallas
Fort Worth, TX
RECRUITING
Fort Worth
Katy, TX
RECRUITING
Katy
Plano, TX
RECRUITING
Plano
Round Rock, TX
RECRUITING
Round Rock
San Antonio, TX
RECRUITING
San Antonio
San Marcos, Texas
RECRUITING
San Marcos
Schertz, TX
RECRUITING
Schertz
The Woodlands, TX
RECRUITING
The Woodlands
Willow Park, TX
RECRUITING
Willow Park
Utah
Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Lynchburg, VA
RECRUITING
Lynchburg
Richmond, VA
RECRUITING
Richmond
Washington
Burlington, Washington
RECRUITING
Burlington
Spokane, WA
RECRUITING
Spokane
Other Locations
Argentina
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITING
Buenos Aires
Cordoba, Argentina
NOT_YET_RECRUITING
Córdoba
Cordoba, Argentina
NOT_YET_RECRUITING
Córdoba
Salta, Argentina
NOT_YET_RECRUITING
Salta
Salta, Argentina
NOT_YET_RECRUITING
Salta
Santa Fe, Argentina
NOT_YET_RECRUITING
Santa Fe
Brazil
Aparecida de Goiania, Brazil
NOT_YET_RECRUITING
Aparecida De Goiânia
Aparecida De Goiania, Brazil
NOT_YET_RECRUITING
Aparecida De Goiânia
Assis, Brazil
NOT_YET_RECRUITING
Assis
Belo Horizonte, Brazil
NOT_YET_RECRUITING
Belo Horizonte
Blumenau, Brazil
RECRUITING
Blumenau
Porto Alegre, Brazil
NOT_YET_RECRUITING
Porto Alegre
Sao Paulo, Brazil
NOT_YET_RECRUITING
São Paulo
Sao Paulo, Brazil
RECRUITING
São Paulo
Sorocaba, Brazil
RECRUITING
Sorocaba
Vitoria, Brazil
NOT_YET_RECRUITING
Vitória
Colombia
Barranquilla, Colombia
NOT_YET_RECRUITING
Barranquilla
Bogata, Colombia
NOT_YET_RECRUITING
Bogotá
Medelin, Colombia
NOT_YET_RECRUITING
Medellín
Medellin, Colombia
NOT_YET_RECRUITING
Medellín
Cali, Colombia
NOT_YET_RECRUITING
Santiago De Cali
Puerto Rico
Arecibo, PR
RECRUITING
Arecibo
San Juan, Puerto Rico
RECRUITING
San Juan
Contact Information
Primary
Charles Miller, MD PhD
ClinicalInquiries@eyebiotech.com
212-914-0127
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 960
Treatments
Experimental: EYE103 Low Dose Treatment Arm
EYE103 Low Dose Treatment Arm
Experimental: EYE103 High Dose Treatment Arm
EYE103 High Dose Treatment Arm
Active_comparator: Ranibizumab Treatment Arm
Ranibizumab Treatment Arm
Sponsors
Leads: EyeBiotech Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials