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NCT04563299 · ClinicalTrials.gov registry record · Phase 4
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
A Phase 4 study, sponsored by Retina Vitreous Associates of Florida.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT04563299: Clinical Trial Phase 4 study, sponsored by Retina Vitreous Associates of Florida.
NCT04563299 is a Phase 4 study that was terminated before completion, run by Retina Vitreous Associates of Florida. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04563299, a Phase 4 study, was terminated before completion, sponsored by Retina Vitreous Associates of Florida.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient.
Primary Outcome
As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain)
Interventions
- DRUG Prednisolone Acetate
- DRUG Dextenza 0.4Mg Ophthalmic Insert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2023-02-14 |
| Phase | Phase 4 |
Why NCT04563299 stopped before completion
NCT04563299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisolone Acetate is the first listed.
NCT04563299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04563299 about?
NCT04563299 is a clinical study titled "Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections". This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injecti...
What is the current status of trial NCT04563299?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2020-12-09. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT04563299?
The interventions under investigation include: Prednisolone Acetate (DRUG), Dextenza 0.4Mg Ophthalmic Insert (DRUG).
Who is sponsoring clinical trial NCT04563299?
This trial is sponsored by Retina Vitreous Associates of Florida, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04563299's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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