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NCT03727776 · ClinicalTrials.gov registry record · Early Phase 1
Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT03727776: Completed Early Phase 1 study, sponsored by Johns Hopkins University.
NCT03727776 is a Early Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727776, a Early Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a pilot study to measure levels of albumin and inflammatory cytokines \[including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)\] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adrenocorticotropic hormone (ACTH) analog. The study will be conducted at the Wilmer Eye Institute, Johns Hopkins Hospital. A total of 15 patients will be enrolled and randomized 2:1 to H.P. Acthar® or standard of care. Treatment duration will be 8 weeks and study duration will be 12 weeks. There will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12). Subjects will self-administer subcutaneous injections of 80 units of H.P. Acthar® starting on post-operative day 1 for twice a week until week 8. Subjects in the control arm will be managed per the standard of care. Aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. Aqueous levels of albumin and inflammatory cytokines (including TGF-β and IL-1β) will be measured at each time point.
Primary Outcome
The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
Interventions
- DRUG Adrenocorticotropic Hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2023-07-07 |
| Phase | Early Phase 1 |
What the finished NCT03727776 record still lists
NCT03727776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Adrenocorticotropic Hormone is the first listed.
NCT03727776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03727776 about?
NCT03727776 is a clinical study titled "Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)". This is a pilot study to measure levels of albumin and inflammatory cytokines \[including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)\] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adr...
What is the current status of trial NCT03727776?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2019-08-19. Estimated completion is 2023-07-07.
What interventions are being tested in trial NCT03727776?
The interventions under investigation include: Adrenocorticotropic Hormone (DRUG).
Who is sponsoring clinical trial NCT03727776?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03727776's enrollment target sits among peer trials
11 1601st of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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