Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)

Alimera Sciences

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema (DME)

Treatments: Drug: ILUVIEN 0.19 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02424019

M-01-15-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

ILUVIEN 0.19 MG

Experimental group

Description:

All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.

Treatment:

Drug: ILUVIEN 0.19 MG