Risk factors associated with intraocular pressure increase in patients with uveitis treated with the fluocinolone acetonide implant

Anjali Parekh, Sunil Srivastava, James Bena, Thomas Albini, Quan Dong Nguyen, Debra A. Goldstein

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

IMPORTANCE: Elevated intraocular pressure (IOP) is a well-known adverse event associated with the fluocinolone acetonide implant (FAI), but no data are available regarding factors associated with increased risk of IOP elevation in patients treated with the FAI. OBJECTIVE: To report risk factors that may predispose patients to elevated IOP after treatment with the FAI. DESIGN, SETTING, AND PARTICIPANTS: Data from 3 multicenter, 3-year, prospective, randomized, phase 2b/3 clinical trials evaluating the safety and efficacy of the FAI were pooled and analyzed. Patients had no underlying glaucoma and at least one eye with a history of recurrent noninfectious uveitis affecting the posterior segment. Patients were treated with 1 or more of the following: systemic therapy (corticosteroids or other immunosuppressive drugs) for at least 3 months before enrollment, 2 or more sub-Tenon capsule corticosteroid injections for uveitis management during the 6 months before enrollment, or systemic corticosteroid or sub-Tenon capsule corticosteroid injection therapy required for at least 2 separate recurrences within 6 months before enrollment. MAIN OUTCOMESAND MEASURES: Factors evaluated as risk factors for IOP elevation included age, sex, lens status, uveitis severity at enrollment, and location of uveitis. RESULTS: Data analyses were based on 641 eyes. A total of 351 eyes did not receive the FAI, whereas 290 eyes had the 0.59-mg FAI placed. An increase in IOP of 10mmHgor elevation to30 mm Hg was seenin 60untreated eyes (17.1%) and 188 treated eyes (65.1%) (hazard ratio, 5.80; 95% CI, 4.28-7.70; P <.001). A total of 8 untreated eyes (2.3%) required surgical intervention for elevated IOP compared with 93 treated eyes (32.1%) (hazard ratio, 16.48; 95% CI, 8.24-32.96; P <.001). In patients with the FAI, younger age, male sex, and phakic lens status were associated with higher risk of IOP elevation and the need for glaucoma surgery (P =.003, P <.001, and P <.001, respectively). CONCLUSIONS AND RELEVANCE: Patients receiving the FAI are at higher risk of developing an IOP increaseof 10 mm Hg or anabsolute IOP of30 mm Hg when compared with patients without the FAI. Patients who are male, younger, and phakic are at an even higher risk for elevated IOP and possibly glaucoma surgery.

Original languageEnglish (US)
Pages (from-to)568-573
Number of pages6
JournalJAMA Ophthalmology
Volume133
Issue number5
DOIs
StatePublished - May 1 2015

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Fluocinolone Acetonide
Uveitis
Intraocular Pressure
Adrenal Cortex Hormones
Tenon Capsule
Glaucoma
Lenses
Posterior Uveitis
Phase III Clinical Trials
Injections
Immunosuppressive Agents
Therapeutics

ASJC Scopus subject areas

  • Ophthalmology

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Risk factors associated with intraocular pressure increase in patients with uveitis treated with the fluocinolone acetonide implant. / Parekh, Anjali; Srivastava, Sunil; Bena, James; Albini, Thomas; Nguyen, Quan Dong; Goldstein, Debra A.

In: JAMA Ophthalmology, Vol. 133, No. 5, 01.05.2015, p. 568-573.

Research output: Contribution to journalArticle

Parekh, Anjali ; Srivastava, Sunil ; Bena, James ; Albini, Thomas ; Nguyen, Quan Dong ; Goldstein, Debra A. / Risk factors associated with intraocular pressure increase in patients with uveitis treated with the fluocinolone acetonide implant. In: JAMA Ophthalmology. 2015 ; Vol. 133, No. 5. pp. 568-573.
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AU - Bena, James

AU - Albini, Thomas

AU - Nguyen, Quan Dong

AU - Goldstein, Debra A.

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N2 - IMPORTANCE: Elevated intraocular pressure (IOP) is a well-known adverse event associated with the fluocinolone acetonide implant (FAI), but no data are available regarding factors associated with increased risk of IOP elevation in patients treated with the FAI. OBJECTIVE: To report risk factors that may predispose patients to elevated IOP after treatment with the FAI. DESIGN, SETTING, AND PARTICIPANTS: Data from 3 multicenter, 3-year, prospective, randomized, phase 2b/3 clinical trials evaluating the safety and efficacy of the FAI were pooled and analyzed. Patients had no underlying glaucoma and at least one eye with a history of recurrent noninfectious uveitis affecting the posterior segment. Patients were treated with 1 or more of the following: systemic therapy (corticosteroids or other immunosuppressive drugs) for at least 3 months before enrollment, 2 or more sub-Tenon capsule corticosteroid injections for uveitis management during the 6 months before enrollment, or systemic corticosteroid or sub-Tenon capsule corticosteroid injection therapy required for at least 2 separate recurrences within 6 months before enrollment. MAIN OUTCOMESAND MEASURES: Factors evaluated as risk factors for IOP elevation included age, sex, lens status, uveitis severity at enrollment, and location of uveitis. RESULTS: Data analyses were based on 641 eyes. A total of 351 eyes did not receive the FAI, whereas 290 eyes had the 0.59-mg FAI placed. An increase in IOP of 10mmHgor elevation to30 mm Hg was seenin 60untreated eyes (17.1%) and 188 treated eyes (65.1%) (hazard ratio, 5.80; 95% CI, 4.28-7.70; P <.001). A total of 8 untreated eyes (2.3%) required surgical intervention for elevated IOP compared with 93 treated eyes (32.1%) (hazard ratio, 16.48; 95% CI, 8.24-32.96; P <.001). In patients with the FAI, younger age, male sex, and phakic lens status were associated with higher risk of IOP elevation and the need for glaucoma surgery (P =.003, P <.001, and P <.001, respectively). CONCLUSIONS AND RELEVANCE: Patients receiving the FAI are at higher risk of developing an IOP increaseof 10 mm Hg or anabsolute IOP of30 mm Hg when compared with patients without the FAI. Patients who are male, younger, and phakic are at an even higher risk for elevated IOP and possibly glaucoma surgery.

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