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NCT03835884 · ClinicalTrials.gov registry record · Phase 1
A Study Assessing AR-13503 Implant in Subjects With nAMD or DME
A Phase 1 study, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03835884: Completed Phase 1 study, sponsored by Aerie Pharmaceuticals.
NCT03835884 is a Phase 1 study that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835884, a Phase 1 study, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
Primary Outcome
Number of ocular and non-ocular treatment-emergent adverse events (TEAEs), summarized at the subject level by system organ class and preferred term, and also by severity and relatedness to treatment.
Interventions
- DRUG AR-13503 Implant 10.6 Dose
- DRUG AR-13503 Implant 21.2 Dose
- DRUG AR-13503 42.4 Dose
- DRUG AR-13503 63.6 Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 1 |
What the finished NCT03835884 record still lists
NCT03835884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which AR-13503 Implant 10.6 Dose is the first listed.
NCT03835884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03835884 about?
NCT03835884 is a clinical study titled "A Study Assessing AR-13503 Implant in Subjects With nAMD or DME". First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
What is the current status of trial NCT03835884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-06-24. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT03835884?
The interventions under investigation include: AR-13503 Implant 10.6 Dose (DRUG), AR-13503 Implant 21.2 Dose (DRUG), AR-13503 42.4 Dose (DRUG), AR-13503 63.6 Dose (DRUG).
Who is sponsoring clinical trial NCT03835884?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03835884's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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