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) (AMARONE)
Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME)
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (NVAMD) focused on measuring Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME), Age-related Macular Degeneration (AMD)
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 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 Exclusion Criteria: 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
Sites / Locations
- Phoenix, AZRecruiting
- Modesto, CARecruiting
- Mountain View, CARecruiting
- Sacramento, CARecruiting
- Sacramento, CARecruiting
- Lakewood, CORecruiting
- Pompano BeachRecruiting
- Lemont, NVRecruiting
- Hagerstown, MDRecruiting
- Reno, NVRecruiting
- West Columbia, SCRecruiting
- Germantown, TNRecruiting
- Knoxville, TNRecruiting
- Nashville, TNRecruiting
- Abilene, TXRecruiting
- Amarillo, TXRecruiting
- Austin, TXRecruiting
- Bellaire, TXRecruiting
- Katy, TXRecruiting
- McAllen, TXRecruiting
- Round Rock, TXRecruiting
- San Antonio, TXRecruiting
- The Woodlands, TXRecruiting
- Ciudad Autonoma Buenos AiresRecruiting
- Arecibo, PRRecruiting
- London, UKRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose 1
Dose 2
Dose 3
Dose 4
DME Medium Dose
DME High Dose
Naïve NVAMD Medium Dose
Naïve NVAMD High Dose
Experienced NVAMD Medium Dose
Experienced NVAMD High Dose
Part 1 MAD Portion Dose 1 - Low Dose
Part 1 MAD Portion Dose 2 - Low-Mid Dose
Part 1 MAD Portion Dose 3 - Mid-High Dose
Part 1 MAD Portion Dose 4 - High Dose
Part 2 Naïve DME monotherapy Medium Dose
Part 2 Naïve DME monotherapy High Dose
Part 2 Naïve NVAMD combination therapy Medium Dose
Part 2 Naïve NVAMD combination therapy High Dose
Part 2 Experienced NVAMD combination therapy Medium Dose
Part 2 Experienced NVAMD combination therapy High Dose