ACTIVE_NOT_RECRUITING

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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) 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.

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

Quick Facts

Study Start:2024-08-07
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06571045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  2. * Be male or female ≥18 years of age.
  3. * Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%.
  4. * Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
  1. * Be pregnant or breastfeeding
  2. * History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
  3. * Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
  4. * Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
  5. * If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
  6. * 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
  7. * 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

Contacts and Locations

Principal Investigator

Charles Miller, MD PhD
STUDY_DIRECTOR
EyeBiotech Ltd.

Study Locations (Sites)

Scottsdale
Scottsdale, Arizona, 85255
United States
Fayetteville, Arkansas
Fayetteville, Arkansas, 72703
United States
Springdale, Arkansas
Springdale, Arkansas, 72764
United States
Bakersfield, CA
Bakersfield, California, 93309
United States
Glendale, CA
Glendale, California, 91204
United States
Modesto, CA
Modesto, California, 95356
United States
Mountain View, CA
Mountain View, California, 94040
United States
Redlands, CA
Redlands, California, 92374
United States
Sacramento, CA
Sacramento, California, 95825
United States
Sacramento, CA
Sacramento, California, 95841
United States
Santa Ana
Santa Ana, California, 92705
United States
Colorado Springs, CO
Colorado Springs, Colorado, 80909
United States
Denver, Colorado
Denver, Colorado, 80210
United States
Danbury, CT
Danbury, Connecticut, 06810
United States
Manchester, CT
Manchester, Connecticut, 06042
United States
Waterford,CT
Waterford, Connecticut, 06385
United States
Deerfield Beach, FL
Deerfield Beach, Florida, 33064
United States
Fort Lauderdale, FL
Fort Lauderdale, Florida, 33308
United States
Fort Myers,FL
Fort Myers, Florida, 33912
United States
Gainesville, FL
Gainesville, Florida, 32607
United States
Orlando, Florida
Orlando, Florida, 32806
United States
Plantation, FL
Plantation, Florida, 33324
United States
Saint Petersburg, FL
Saint Petersburg, Florida, 33711
United States
Sarasota, FL
Sarasota, Florida, 34232
United States
Tallahassee, FL
Tallahassee, Florida, 32308
United States
Tampa, FL
Tampa, Florida, 33609-4614
United States
Tampa, FL
Tampa, Florida, 33617
United States
Winter Haven, FL
Winter Haven, Florida, 33880
United States
Lemont, IL
Lemont, Illinois, 60439
United States
Springfield, Illinois
Springfield, Illinois, 62702
United States
West Des Moines, IA
West Des Moines, Iowa, 50266
United States
Lenexa, Kansas
Lenexa, Kansas, 66215
United States
Wichita, Kansas
Wichita, Kansas, 67214
United States
Portland, Maine
Portland, Maine, 04101
United States
Hagerstown, MD
Hagerstown, Maryland, 21740
United States
Springfield,MA
Springfield, Massachusetts, 01107
United States
Grand Rapids, Michigan
Grand Rapids, Michigan, 49546
United States
Minneapolis, MN
Minneapolis, Minnesota, 55435
United States
Madison, MS
Madison, Mississippi, 39110
United States
Bloomfield, NJ
Bloomfield, New Jersey, 07003
United States
Cherry Hill, NJ
Cherry Hill, New Jersey, 08034
United States
Liverpool, NY
Liverpool, New York, 13088
United States
Oceanside, NY
Oceanside, New York, 11572
United States
Rochester, NY
Rochester, New York, 14620
United States
Asheville, NC
Asheville, North Carolina, 28803
United States
Hickory, NC
Hickory, North Carolina, 28602
United States
Wake Forest, MC
Wake Forest, North Carolina, 27587
United States
Winston Salem, NC
Winston-Salem, North Carolina, 27103
United States
Cleveland, Ohio
Cleveland, Ohio, 44122
United States
Cleveland, OH
Cleveland, Ohio, 44130
United States
Youngstown, Ohio
Youngstown, Ohio, 44505
United States
Edmond, OK
Edmond, Oklahoma, 73013
United States
Portland, OR
Portland, Oregon, 97221
United States
Springfield, Oregon
Springfield, Oregon, 97477
United States
Bethlehem, PA
Bethlehem, Pennsylvania, 18017
United States
Erie, PA
Erie, Pennsylvania, 16507
United States
Beaufort, SC
Beaufort, South Carolina, 29902
United States
Florence, SC
Florence, South Carolina, 29501
United States
Ladson, SC
Ladson, South Carolina, 29456
United States
West Columbia, SC
West Columbia, South Carolina, 29169
United States
Germantown, TN
Germantown, Tennessee, 38138
United States
Hixson, Tennessee
Hixson, Tennessee, 37343
United States
Johnson City, Tennessee
Johnson City, Tennessee, 37604
United States
Knoxville, TN
Knoxville, Tennessee, 37922
United States
Nashville, TN
Nashville, Tennessee, 37203
United States
Abilene, TX
Abilene, Texas, 79606
United States
Amarillo, TX
Amarillo, Texas, 79106
United States
Amarillo, TX
Amarillo, Texas, 79109
United States
Arlington, TX
Arlington, Texas, 76012
United States
Austin, TX
Austin, Texas, 78705
United States
Beaumont, TX
Beaumont, Texas, 77707
United States
Bellaire, TX
Bellaire, Texas, 77401
United States
Dallas, TX
Dallas, Texas, 75231
United States
Fort Worth, TX
Fort Worth, Texas, 76104
United States
Katy, TX
Katy, Texas, 77494
United States
Plano, TX
Plano, Texas, 75075
United States
Round Rock, TX
Round Rock, Texas, 78681
United States
San Antonio, TX
San Antonio, Texas, 78240
United States
Schertz, Texas
Schertz, Texas, 78154
United States
The Woodlands, TX
The Woodlands, Texas, 77384
United States
Willow Park, TX
Willow Park, Texas, 76087
United States
Salt Lake City, Utah
Salt Lake City, Utah, 84107
United States
Lynchburg, VA
Lynchburg, Virginia, 24502
United States
Richmond, Virginia
Richmond, Virginia, 23235
United States
Spokane, WA
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: EyeBiotech Ltd.

  • Charles Miller, MD PhD, STUDY_DIRECTOR, EyeBiotech Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Diabetic Macular Edema
  • DME

Additional Relevant MeSH Terms

  • Diabetic Macular Edema (DME)