Dissociations of the Fluocinolone Acetonide Implant

The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group

Research output: Contribution to journalArticleResearchpeer-review

6 Citations (Scopus)

Abstract

Purpose: To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Design: Randomized clinical trial with extended follow-up. Methods: Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related. Results: A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5–9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%–9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%–48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P <.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment. Conclusion: There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

Original languageEnglish
Pages (from-to)29-36
Number of pages8
JournalAmerican Journal of Ophthalmology
Volume164
DOIs
StatePublished - 1 Apr 2016

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Fluocinolone Acetonide
Uveitis
Steroids
Visual Acuity
Therapeutics
Drug Implants
Confidence Intervals
Randomized Controlled Trials

Cite this

@article{1540891fdd2049688c5c95dee5ef507b,
title = "Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study",
abstract = "Purpose: To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Design: Randomized clinical trial with extended follow-up. Methods: Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related. Results: A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5–9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8{\%} (95{\%} confidence interval [CI]: 2.4{\%}–9.1{\%}). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26{\%}, 95{\%} CI 15{\%}–48{\%}); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P <.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22{\%} of affected eyes; declines were frequently associated with complications of uveitis or its treatment. Conclusion: There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22{\%} of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.",
author = "{Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group} and Holbrook, {Janet T.} and Sugar, {Elizabeth A.} and Burke, {Alyce E.} and Vitale, {Albert T.} and Thorne, {Jennifer E.} and Davis, {Janet L.} and Jabs, {Douglas A.} and Jaffe, {Glenn J.} and Brenda Branchaud and Paul Hahn and Larry Koreen and Lad, {Eleonora (Nora) M.} and Phoebe Lin and Martel, {Joseph Nissim} and {(Shah) Serrano}, Neha and Cindy Skalak and Lejla Vajzovic and Claxton Baer and Joyce Bryant and Sai Chavala and Sai Chavala and Shelley Day and Pouya Dayani and Justis Ehlers and Muge Kesen and Annie Lee and Alex Melamud and Qureshi, {Jawad A.} and Scott, {Adrienne Williams} and See, {Robert F.} and Shuler, {Robert K.} and Megan Wood and Steven Yeh and Alcides Fernandes and Deborah Gibbs and Donna Leef and Martin, {Daniel F.} and Sunil Srivastava and Dunn, {James P.} and Hosne Begum and Jeff Boring and Brotherson, {Kristen L.} and Bryn Burkholder and Butler, {Nicholas J.} and Dennis Cain and Cook, {Mary A.} and David Emmert and Graul, {Janis R.} and Mark Herring and Ashley Laing",
year = "2016",
month = "4",
day = "1",
doi = "10.1016/j.ajo.2015.12.028",
language = "English",
volume = "164",
pages = "29--36",
journal = "American Journal of Ophthalmology",
issn = "0002-9394",
publisher = "Elsevier USA",

}

Dissociations of the Fluocinolone Acetonide Implant : The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. / Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group.

In: American Journal of Ophthalmology, Vol. 164, 01.04.2016, p. 29-36.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Dissociations of the Fluocinolone Acetonide Implant

T2 - The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

AU - Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group

AU - Holbrook, Janet T.

AU - Sugar, Elizabeth A.

AU - Burke, Alyce E.

AU - Vitale, Albert T.

AU - Thorne, Jennifer E.

AU - Davis, Janet L.

AU - Jabs, Douglas A.

AU - Jaffe, Glenn J.

AU - Branchaud, Brenda

AU - Hahn, Paul

AU - Koreen, Larry

AU - Lad, Eleonora (Nora) M.

AU - Lin, Phoebe

AU - Martel, Joseph Nissim

AU - (Shah) Serrano, Neha

AU - Skalak, Cindy

AU - Vajzovic, Lejla

AU - Baer, Claxton

AU - Bryant, Joyce

AU - Chavala, Sai

AU - Chavala, Sai

AU - Day, Shelley

AU - Dayani, Pouya

AU - Ehlers, Justis

AU - Kesen, Muge

AU - Lee, Annie

AU - Melamud, Alex

AU - Qureshi, Jawad A.

AU - Scott, Adrienne Williams

AU - See, Robert F.

AU - Shuler, Robert K.

AU - Wood, Megan

AU - Yeh, Steven

AU - Fernandes, Alcides

AU - Gibbs, Deborah

AU - Leef, Donna

AU - Martin, Daniel F.

AU - Srivastava, Sunil

AU - Dunn, James P.

AU - Begum, Hosne

AU - Boring, Jeff

AU - Brotherson, Kristen L.

AU - Burkholder, Bryn

AU - Butler, Nicholas J.

AU - Cain, Dennis

AU - Cook, Mary A.

AU - Emmert, David

AU - Graul, Janis R.

AU - Herring, Mark

AU - Laing, Ashley

PY - 2016/4/1

Y1 - 2016/4/1

N2 - Purpose: To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Design: Randomized clinical trial with extended follow-up. Methods: Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related. Results: A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5–9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%–9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%–48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P <.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment. Conclusion: There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

AB - Purpose: To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Design: Randomized clinical trial with extended follow-up. Methods: Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related. Results: A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5–9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%–9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%–48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P <.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment. Conclusion: There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

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U2 - 10.1016/j.ajo.2015.12.028

DO - 10.1016/j.ajo.2015.12.028

M3 - Article

VL - 164

SP - 29

EP - 36

JO - American Journal of Ophthalmology

JF - American Journal of Ophthalmology

SN - 0002-9394

ER -