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A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program

NCT02251938 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-12

Study results available
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Summary

The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.

Conditions

  • Non-Infectious Uveitis of the Posterior Segment of the Eye

Interventions

DRUG

DE-109 440 μg

Medium Dose

Sponsors & Collaborators

  • Santen Inc.

    lead INDUSTRY

Principal Investigators

  • Lanita Scott, MD · Santen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-29
Primary Completion
2017-11-01
Completion
2017-11-27

Countries

  • United States
  • Austria
  • France
  • India
  • Italy
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251938 on ClinicalTrials.gov