Three-Year Safety and Efficacy of the 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: The PALADIN Study.

Abstract

PURPOSE:

To assess the long-term safety and efficacy of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien; Alimera Sciences, Inc) in patients with diabetic macular edema (DME).

DESIGN:

Three-year, phase 4, nonrandomized, open-label observational study.

PARTICIPANTS:

Patients with DME who previously received corticosteroid treatment without a clinically significant rise in intraocular pressure (IOP; all eyes, n = 202 eyes of 159 patients; 36-month completion, n = 94 eyes).

METHODS:

A prospective, observational study in which patients received a 0.19-mg FAc intravitreal implant at baseline and then were observed for safety-, visual-, anatomic-, and treatment burden-related outcomes for up to 36 months.

MAIN OUTCOME MEASURES:

Primary safety outcomes included changes in IOP and interventions to manage IOP elevations. Secondary outcomes included changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and adjunctive DME treatment frequency RESULTS: At 36 months after FAc implantation, study eyes showed a mean CST change of -60.69 μm (P < 0.0001) and a mean BCVA change of +3.61 letters (P = 0.0222) compared with baseline. Overall median treatment frequency decreased from 3.4 treatments/year in the 36 months before FAc implantation to 1 treatment/year in the 36 months after FAc implant, a treatment burden reduction of 70.5%. Furthermore, among the group that completed 36 months of treatment (n = 94 eyes), 25.53% of eyes remained rescue free through 36 months. Mean IOP remained stable throughout the study, and IOP increases to more than 30 mmHg occurred in 10.89% of eyes. Intraocular pressure-related procedures were infrequent, with a surgical rate of 2.97%, with 1.49% attributable to steroid use (vs. surgeries attributable primarily to neovascular glaucoma). In addition, an IOP response of < 25 mmHg after the steroid challenge predicted that 96.92% of eyes would have a similar outcome to 0.19-mg FAc implant at the last visit. Intraocular pressure increases that did occur were manageable with standard treatments (n = 202 eyes).

CONCLUSIONS:

In patients with DME, the 0.19-mg FAc implant provided improved visual outcomes and reduced treatment burden compared with previous treatments while maintaining a favorable safety profile.

• Authors: Michael A Singer, Veeral Sheth, Sam E Mansour, Brandon Coughlin, Victor H Gonzalez
• Journal: Ophthalmology (Ophthalmology) Vol. 129 Issue 6 Pg. 605-613 (06 2022) ISSN: 1549-4713 [Electronic] United States
• PMID: 35063472 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Drug Implants
• Glucocorticoids
• Steroids
• Fluocinolone Acetonide

Topics

• Diabetes Mellitus
• Diabetic Retinopathy (complications, diagnosis, drug therapy)
• Drug Implants (therapeutic use)
• Fluocinolone Acetonide
• Glucocorticoids (therapeutic use)
• Humans
• Intravitreal Injections
• Macular Edema (diagnosis, drug therapy, etiology)
• Prospective Studies
• Steroids (therapeutic use)
• Visual Acuity