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NCT02555306 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

A Phase 1 study, sponsored by Santen.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02555306 is a Phase 1 study that has completed, run by Santen. The registered enrollment target is 12 participants.

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The verdict

NCT02555306, a Phase 1 study, has completed, sponsored by Santen.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

Interventions

  • DRUG 0.5 mg of DE-122
  • DRUG 1.0 mg of DE-122
  • DRUG 2.0 mg of DE-122
  • DRUG 4.0 mg of DE-122

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2015-09-16
Est. Completion 2017-08
Phase Phase 1

Sponsor

Santen

32 total trials

What the Registry Record Tells You About NCT02555306

The ClinicalTrials.gov registry entry for NCT02555306 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which 0.5 mg of DE-122 is the first listed.

NCT02555306 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02555306 about?

NCT02555306 is a clinical study titled "A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration". The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

What is the current status of trial NCT02555306?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-09-16. Estimated completion is 2017-08.

What interventions are being tested in trial NCT02555306?

The interventions under investigation include: 0.5 mg of DE-122 (DRUG), 1.0 mg of DE-122 (DRUG), 2.0 mg of DE-122 (DRUG), 4.0 mg of DE-122 (DRUG).

Who is sponsoring clinical trial NCT02555306?

This trial is sponsored by Santen, which has 32 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.