Phase 4 IOP Signals Associated With ILUVIEN®

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02424019

Acronym

PALADIN

Enrollment

153

Registered

2015-04-22

Start date

2015-05-06

Completion date

2020-07-31

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema (DME)

Brief summary

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

Detailed description

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.

Interventions

DRUGILUVIEN 0.19 MG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Intraocular Pressure	36 months	Intraocular pressure of the ILUVIEN treated eye

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026