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NCT03585556 · ClinicalTrials.gov registry record · Phase 1
AAVCAGsCD59 for the Treatment of Wet AMD
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT03585556: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03585556 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03585556, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of \>50 micrometers on OCT from Day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.
Primary Outcome
Measure the number of intravitreal anti VEGF injections from Month 1 through Month 12 following an intravitreal injection of AAVCAGsCD59 at Day 7
Interventions
- DRUG Oral prednisolone
- DRUG Intravitreal anti-VEGF
- BIOLOGICAL Intravitreal AAVCAGsCD59
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2022-01-18 |
| Phase | Phase 1 |
What the finished NCT03585556 record still lists
NCT03585556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Oral prednisolone is the first listed.
NCT03585556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03585556 about?
NCT03585556 is a clinical study titled "AAVCAGsCD59 for the Treatment of Wet AMD". Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central ...
What is the current status of trial NCT03585556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2018-09-13. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT03585556?
The interventions under investigation include: Oral prednisolone (DRUG), Intravitreal anti-VEGF (DRUG), Intravitreal AAVCAGsCD59 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03585556?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03585556's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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