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OpenTrials
Completed

NCT Number: NCT02424019

Phase 4 IOP Signals Associated With ILUVIEN®

This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

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Key information

Conditions

Diabetic Macular Edema (DME)

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Retina Consultants of Arizona, Phoenix, Arizona, United States

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About this study

The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.

Exclusion criteria

  • Patients who are unable to understand and sign the Informed Consent Form.

Treatment and study plan

ILUVIEN 0.19 MG

Drug

Other names: Fluocinolone Acetonide Intravitreal Implant 0.19 mg

Primary outcomes

  1. Intraocular Pressure

    Time frame: 36 months

    Intraocular pressure of the ILUVIEN treated eye

Sponsors and collaborators

Lead sponsor

Alimera Sciences

Industry

Registry information

Official study title

A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg

Acronym: PALADIN

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2015
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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