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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 25 participants.

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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.

Interventions

  • DRUG Oral prednisolone
  • DRUG Intravitreal anti-VEGF
  • BIOLOGICAL Intravitreal AAVCAGsCD59

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2018-09-13
Est. Completion 2022-01-18
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT03585556

The ClinicalTrials.gov registry entry for NCT03585556 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Oral prednisolone is the first listed.

NCT03585556 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.