A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
- Conditions
- Neovascular Age-related Macular Degeneration (NVAMD)Diabetic Macular Edema (DME)
- Interventions
- Registration Number
- NCT05919693
- Lead Sponsor
- EyeBiotech Ltd.
- Brief Summary
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
- Detailed Description
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age
- Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.
- DME patients must have vision loss in the study eye
- NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye
- Be pregnant or breastfeeding
- History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening
- Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening
- Any other condition except for DME or NVAMD or that could affect interpretation of study assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose 3 EYE103 Part 1 MAD Portion Dose 3 - Mid-High Dose Dose 1 EYE103 Part 1 MAD Portion Dose 1 - Low Dose Dose 2 EYE103 Part 1 MAD Portion Dose 2 - Low-Mid Dose DME Medium Dose EYE103 Part 2 Naïve DME monotherapy Medium Dose DME High Dose EYE103 Part 2 Naïve DME monotherapy High Dose Naïve NVAMD Medium Dose EYE103 Part 2 Naïve NVAMD combination therapy Medium Dose Naïve NVAMD High Dose EYE103 Part 2 Naïve NVAMD combination therapy High Dose Experienced NVAMD Medium Dose EYE103 Part 2 Experienced NVAMD combination therapy Medium Dose Experienced NVAMD High Dose EYE103 Part 2 Experienced NVAMD combination therapy High Dose Dose 4 EYE103 Part 1 MAD Portion Dose 4 - High Dose
- Primary Outcome Measures
Name Time Method Adverse Events 3 months Adverse Events
- Secondary Outcome Measures
Name Time Method Best-corrected Visual Acuity 3 months Best-corrected Visual Acuity
Trial Locations
- Locations (31)
Phoenix, AZ
🇺🇸Phoenix, Arizona, United States
Bakersfield, CA
🇺🇸Bakersfield, California, United States
Modesto, CA
🇺🇸Modesto, California, United States
Mountain View, CA
🇺🇸Mountain View, California, United States
Sacramento, CA
🇺🇸Sacramento, California, United States
Colorado Springs, Colorado
🇺🇸Colorado Springs, Colorado, United States
Lakewood, CO
🇺🇸Lakewood, Colorado, United States
Pompano Beach
🇺🇸Pompano Beach, Florida, United States
Lemont, NV
🇺🇸Lemont, Illinois, United States
Hagerstown, MD
🇺🇸Hagerstown, Maryland, United States
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