A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
Purpose
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.
Condition
- Diabetic Macular Edema (DME)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel enrollment into 1 of 3 arms
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Scottsdale
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
Fayetteville, Arkansas
Fayetteville, Arkansas 72703
Fayetteville, Arkansas 72703
Springdale, Arkansas
Springdale, Arkansas 72764
Springdale, Arkansas 72764
Bakersfield, CA
Bakersfield, California 93309
Bakersfield, California 93309
Glendale, CA
Glendale, California 91204
Glendale, California 91204
Modesto, CA
Modesto, California 95356
Modesto, California 95356
Mountain View, CA
Mountain View, California 94040
Mountain View, California 94040
Redlands, CA
Redlands, California 92374
Redlands, California 92374
Sacramento, CA
Sacramento, California 95825
Sacramento, California 95825
Sacramento, CA
Sacramento, California 95841
Sacramento, California 95841
Santa Ana
Santa Ana, California 92705
Santa Ana, California 92705
Colorado Springs, CO
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Denver, Colorado
Denver, Colorado 80210
Denver, Colorado 80210
Danbury, CT
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Manchester, CT
Manchester, Connecticut 06042
Manchester, Connecticut 06042
Waterford,CT
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Deerfield Beach, FL
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Fort Lauderdale, FL
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Fort Myers,FL
Fort Myers, Florida 33912
Fort Myers, Florida 33912
Gainesville, FL
Gainesville, Florida 32607
Gainesville, Florida 32607
Orlando, Florida
Orlando, Florida 32806
Orlando, Florida 32806
Plantation, FL
Plantation, Florida 33324
Plantation, Florida 33324
Saint Petersburg, FL
Saint Petersburg, Florida 33711
Saint Petersburg, Florida 33711
Sarasota, FL
Sarasota, Florida 34232
Sarasota, Florida 34232
Tallahassee, FL
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Tampa, FL
Tampa, Florida 33609-4614
Tampa, Florida 33609-4614
Tampa, FL
Tampa, Florida 33617
Tampa, Florida 33617
Winter Haven, FL
Winter Haven, Florida 33880
Winter Haven, Florida 33880
Lemont, IL
Lemont, Illinois 60439
Lemont, Illinois 60439
Springfield, Illinois
Springfield, Illinois 62702
Springfield, Illinois 62702
West Des Moines, IA
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Lenexa, Kansas
Lenexa, Kansas 66215
Lenexa, Kansas 66215
Wichita, Kansas
Wichita, Kansas 67214
Wichita, Kansas 67214
Portland, Maine
Portland, Maine 04101
Portland, Maine 04101
Hagerstown, MD
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Springfield,MA
Springfield, Massachusetts 01107
Springfield, Massachusetts 01107
Grand Rapids, Michigan
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Minneapolis, MN
Minneapolis, Minnesota 55435
Minneapolis, Minnesota 55435
Madison, MS
Madison, Mississippi 39110
Madison, Mississippi 39110
Bloomfield, NJ
Bloomfield, New Jersey 07003
Bloomfield, New Jersey 07003
Cherry Hill, NJ
Cherry Hill, New Jersey 08034
Cherry Hill, New Jersey 08034
Liverpool, NY
Liverpool, New York 13088
Liverpool, New York 13088
Oceanside, NY
Oceanside, New York 11572
Oceanside, New York 11572
Rochester, NY
Rochester, New York 14620
Rochester, New York 14620
Asheville, NC
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Hickory, NC
Hickory, North Carolina 28602
Hickory, North Carolina 28602
Wake Forest, MC
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
Winston Salem, NC
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Cleveland, Ohio
Cleveland, Ohio 44122
Cleveland, Ohio 44122
Cleveland, OH
Cleveland, Ohio 44130
Cleveland, Ohio 44130
Youngstown, Ohio
Youngstown, Ohio 44505
Youngstown, Ohio 44505
Edmond, OK
Edmond, Oklahoma 73013
Edmond, Oklahoma 73013
Portland, OR
Portland, Oregon 97221
Portland, Oregon 97221
Springfield, Oregon
Springfield, Oregon 97477
Springfield, Oregon 97477
Bethlehem, PA
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Erie, PA
Erie, Pennsylvania 16507
Erie, Pennsylvania 16507
Beaufort, SC
Beaufort, South Carolina 29902
Beaufort, South Carolina 29902
Florence, SC
Florence, South Carolina 29501
Florence, South Carolina 29501
Ladson, SC
Ladson, South Carolina 29456
Ladson, South Carolina 29456
West Columbia, SC
West Columbia, South Carolina 29169
West Columbia, South Carolina 29169
Germantown, TN
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Hixson, Tennessee
Hixson, Tennessee 37343
Hixson, Tennessee 37343
Johnson City, Tennessee
Johnson City, Tennessee 37604
Johnson City, Tennessee 37604
Knoxville, TN
Knoxville, Tennessee 37922
Knoxville, Tennessee 37922
Nashville, TN
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Abilene, TX
Abilene, Texas 79606
Abilene, Texas 79606
Amarillo, TX
Amarillo, Texas 79106
Amarillo, Texas 79106
Amarillo, TX
Amarillo, Texas 79109
Amarillo, Texas 79109
Arlington, TX
Arlington, Texas 76012
Arlington, Texas 76012
Austin, TX
Austin, Texas 78705
Austin, Texas 78705
Beaumont, TX
Beaumont, Texas 77707
Beaumont, Texas 77707
Bellaire, TX
Bellaire, Texas 77401
Bellaire, Texas 77401
Dallas, TX
Dallas, Texas 75231
Dallas, Texas 75231
Fort Worth, TX
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Katy, TX
Katy, Texas 77494
Katy, Texas 77494
Plano, TX
Plano, Texas 75075
Plano, Texas 75075
Round Rock, TX
Round Rock, Texas 78681
Round Rock, Texas 78681
San Antonio, TX
San Antonio, Texas 78240
San Antonio, Texas 78240
Schertz, Texas
Schertz, Texas 78154
Schertz, Texas 78154
The Woodlands, TX
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Willow Park, TX
Willow Park, Texas 76087
Willow Park, Texas 76087
Salt Lake City, Utah
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Lynchburg, VA
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
Richmond, Virginia
Richmond, Virginia 23235
Richmond, Virginia 23235
Spokane, WA
Spokane, Washington 99204
Spokane, Washington 99204
Arecibo, PR
Arecibo, Puerto Rico 00612
Arecibo, Puerto Rico 00612
More Details
- NCT ID
- NCT06571045
- Status
- Recruiting
- Sponsor
- EyeBiotech Ltd.
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.