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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: Completed Phase 1 study, sponsored by EyeBiotech.

NCT05919693 is a Phase 1 study that has completed, run by EyeBiotech. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Adverse Events

Interventions

  • DRUG EYE103

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2023-06-12
Est. Completion 2024-08-26
Phase Phase 1
EyeBiotech

7 total trials

What the finished NCT05919693 record still lists

NCT05919693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 1 intervention - of which EYE103 is the first listed.

NCT05919693 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05919693's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05919693, the US trial registry maintained by the National Library of Medicine. NCT05919693 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.