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NCT05919693 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by EyeBiotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT05919693 is a Phase 1 study that has completed, run by EyeBiotech. The registered enrollment target is 33 participants.
The verdict
NCT05919693, a Phase 1 study, has completed, sponsored by EyeBiotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Interventions
- DRUG EYE103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2024-08-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05919693
The ClinicalTrials.gov registry entry for NCT05919693 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EyeBiotech, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EYE103 is the first listed.
NCT05919693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05919693 about?
NCT05919693 is a clinical study titled "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)". 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...
What is the current status of trial NCT05919693?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2023-06-12. Estimated completion is 2024-08-26.
What interventions are being tested in trial NCT05919693?
The interventions under investigation include: EYE103 (DRUG).
Who is sponsoring clinical trial NCT05919693?
This trial is sponsored by EyeBiotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
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