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NCT04697758 · ClinicalTrials.gov registry record · Phase 1
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
A Phase 1 study, sponsored by AsclepiX Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04697758: Clinical Trial Phase 1 study, sponsored by AsclepiX Therapeutics.
NCT04697758 is a Phase 1 study that was terminated before completion, run by AsclepiX Therapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697758, a Phase 1 study, was terminated before completion, sponsored by AsclepiX Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
Primary Outcome
Incidence of ocular (study eye) and systemic AEs
Interventions
- DRUG AXT107 0.1 mg
- DRUG AXT107 0.25 mg
- DRUG AXT107 0.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2022-10-01 |
| Phase | Phase 1 |
Why NCT04697758 stopped before completion
NCT04697758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which AXT107 0.1 mg is the first listed.
NCT04697758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04697758 about?
NCT04697758 is a clinical study titled "Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema". This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
What is the current status of trial NCT04697758?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-12-10. Estimated completion is 2022-10-01.
What interventions are being tested in trial NCT04697758?
The interventions under investigation include: AXT107 0.1 mg (DRUG), AXT107 0.25 mg (DRUG), AXT107 0.5 mg (DRUG).
Who is sponsoring clinical trial NCT04697758?
This trial is sponsored by AsclepiX Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04697758's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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