Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD)
Conditions
Keywords
Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME), Age-related Macular Degeneration (AMD)
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.
Interventions
DRUGEYE103
EYE103 is a humanized antibody formulated for IVT administration
Sponsors
EyeBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participant Care Provider Outcomes Assessor
Intervention model description
Part 1 is a multiple-dose escalation study and patients will be enrolled sequentially in ascending order through the dose levels until the highest level is reached or until a maximum tolerated dose is reached, whichever comes first. Part 2 is randomized single-masked study where patients on all arms will be enrolled in parallel.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 months | Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected Visual Acuity | 3 months | Best-corrected Visual Acuity |
Countries
Argentina, Puerto Rico, United Kingdom, United States
Outcome results
None listed