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Phase 4 IOP Signals Associated With ILUVIEN® | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT02424019•Alimera Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

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.

Locations (41)

Retina Consultants of Arizona

Phoenix, Arizona, United States

Retina Centers, P.C.

Tucson, Arizona, United States

Retina and Macula Institute

Glendale, California, United States

Atlantis Eye Care

Huntington Beach, California, United States

Northern California Retina Vitreous Medical Group, Inc.

Mountain View, California, United States

Orange County Retina Medical Group

Santa Ana, California, United States

Eye Care Center of Northern Colorado

Longmont, Colorado, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Southeast Retina Center, P.C.

Augusta, Georgia, United States

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Key Dates

Start Date

May 6, 2015

Primary Completion Date

July 29, 2020

Completion Date

July 31, 2020

Last Updated

January 11, 2022

Enrollment

153

ACTUAL participants

Conditions

Diabetic Macular Edema (DME)

Interventions

ILUVIEN 0.19 MG

DRUG

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

View study

RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 4 IOP Signals Associated With ILUVIEN®

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

A Study of Avoralstat In Participants With Diabetic Macular Edema

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting