TY - JOUR
T1 - The 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema
T2 - Intraocular Pressure-Related Effects over 36 Months
AU - PALADIN Study Group
AU - Roth, Daniel B.
AU - Eichenbaum, David
AU - Malik, Deepika
AU - Radcliffe, Nathan M.
AU - Cutino, Antonio
AU - Small, Kent W.
AU - Abdelsalam, Ahmed
AU - Shakoor, Akbar
AU - Moshiri, Ala
AU - Barkmeier, Andrew
AU - Tewari, Asheesh
AU - Baker, Carl
AU - Kiernan, Daniel
AU - Rosberger, Daniel
AU - Roth, Daniel
AU - Marcus, Dennis
AU - Dehning, Doug
AU - Reichel, Elias
AU - Tilton, Elisha
AU - Fu, Evelyn
AU - Kokame, Gregg
AU - Salehi-Had, Hani
AU - Bhatt, Harit
AU - Nielsen, Jared
AU - Prensky, Jay
AU - Lim, Jennifer
AU - Adleberg, Jon
AU - Beck, Joseph
AU - Gunn, Joseph
AU - Podhorzer, Joseph
AU - Small, Kent
AU - Kooragayala, Lakshmana
AU - Freisberg, Lars
AU - Schocket, Lisa
AU - Berrocal, Maria
AU - Worrall, Martin
AU - Cassell, Michael
AU - Singer, Michael
AU - Tsipursky, Michael
AU - Holekamp, Nancy
AU - Weber, Pamela
AU - Merrill, Pauline
AU - Campochiaro, Peter
AU - Dugel, Pravin
AU - Khurana, Rahul
AU - Apte, Rajendra
AU - Rathod, Rajiv
AU - Katz, Randy
AU - Chace, Richard
AU - Kwun, Robert
N1 - Publisher Copyright:
© 2023 American Academy of Ophthalmology
PY - 2024/1
Y1 - 2024/1
N2 - Purpose: To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME). Design: Secondary analysis of a 36-month, phase IV, nonrandomized, open-label, observational study. Participants: The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication. Methods: Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant. Results: Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan–Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable. Conclusions: Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
AB - Purpose: To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME). Design: Secondary analysis of a 36-month, phase IV, nonrandomized, open-label, observational study. Participants: The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication. Methods: Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant. Results: Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan–Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable. Conclusions: Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
KW - Corticosteroid
KW - Diabetic macular edema
KW - Fluocinolone acetonide
KW - Intraocular pressure
KW - Intravitreal implant
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U2 - 10.1016/j.oret.2023.08.004
DO - 10.1016/j.oret.2023.08.004
M3 - Article
C2 - 37586482
AN - SCOPUS:85173120136
SN - 2468-7219
VL - 8
SP - 49
EP - 54
JO - Ophthalmology Retina
JF - Ophthalmology Retina
IS - 1
ER -