Trials / Completed
CompletedNCT05919693
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)
A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- EyeBiotech Ltd. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EYE103 | EYE103 is a humanized antibody formulated for IVT administration |
Timeline
- Start date
- 2023-06-12
- Primary completion
- 2024-08-26
- Completion
- 2024-08-26
- First posted
- 2023-06-26
- Last updated
- 2025-11-20
Locations
32 sites across 4 countries: United States, Argentina, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05919693. Inclusion in this directory is not an endorsement.