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Review
. 2023 Aug 29;8(8):CD010469.
doi: 10.1002/14651858.CD010469.pub4.

Corticosteroid implants for chronic non-infectious uveitis

Amit Reddy  1 , Su-Hsun Liu  1   2 , Christopher J Brady  3   4 , Pamela C Sieving  5 , Alan G Palestine  1
Affiliations
Review

Corticosteroid implants for chronic non-infectious uveitis

Amit Reddy et al. Cochrane Database Syst Rev. .

Abstract

Background: Uveitis is a term used to describe a group of intraocular inflammatory diseases. Uveitis is the fifth most common cause of vision loss in high-income countries, with the highest incidence of disease in the working-age population. Corticosteroids are the mainstay of treatment for all subtypes of non-infectious uveitis. They can be administered orally, topically with drops, by periocular (around the eye) or intravitreal (inside the eye) injection, or by surgical implantation.

Objectives: To determine the efficacy and safety of steroid implants in people with chronic non-infectious posterior uveitis, intermediate uveitis, and panuveitis.

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE Ovid, Embase, PubMed, LILACS, and three trials registries to November 2021.

Selection criteria: We included randomized controlled trials comparing either fluocinolone acetonide (FA) or dexamethasone (DEX) intravitreal implants with standard-of-care therapy or sham procedures, with at least six months of follow-up after treatment. We included studies that enrolled participants of all ages, who had chronic non-infectious posterior uveitis, intermediate uveitis, or panuveitis with vision that was better than hand-motion.

Data collection and analysis: We applied standard Cochrane methodology.

Main results: We included data from four trials (683 participants, 907 eyes) that compared corticosteroid implants with either sham or standard-of-care therapy. Study characteristics and risk of bias Of the two trials that compared corticosteroid implants with sham procedure, one examined a 0.18 mg FA implant, and the other, a 0.7 mg DEX implant. The other two trials compared a 0.59 mg FA implant with standard-of-care therapy, which included systemic corticosteroids and immunosuppressive medications, if needed. Considering improvement in visual acuity, we assessed the four trials to be at either low risk, or with some concerns of risk of bias across all domains. Findings Using sham procedure as control, combined results at the six-month primary time point suggested that corticosteroid implants may decrease the risk of uveitis recurrence by 60% (relative risk [RR] 0.40, 95% confidence interval [CI] 0.30 to 0.54; 2 trials, 282 participants; low-certainty evidence); and lead to a greater improvement in best-corrected visual acuity (BCVA; mean difference [MD] 0.15 logMAR, 95% CI 0.06 to 0.24; 1 trial, 153 participants; low-certainty evidence). Evidence based on a single-study report (146 participants) suggested that steroid implants may have no effects on visual functioning quality of life, measured on the National Eye Institute 25-Item Visual Function Questionnaire (MD 2.85, 95%CI -3.64 to 9.34; 1 trial, 146 participants; moderate-certainty evidence). Using standard-of care therapy as control, combined estimates at the 24-month primary time point suggested that corticosteroid implants were likely to decrease the risk of recurrence of uveitis by 54% (RR 0.46, 95% CI 0.35 to 0.60; 2 trials, 619 eyes). Combined estimates at 24 months also suggested that steroid implants may have little to no effects on improving BCVA (MD 0.05 logMAR, 95% CI -0.02 to 0.12; 2 trials, 619 eyes; low-certainty evidence). Evidence based on a single-study report (232 participants) suggested that steroid implants may have minimal clinical effects on visual functioning (MD 4.64, 95% CI 0.13 to 9.15; 1 trial, 232 participants; moderate-certainty evidence); physical functioning (SF-36 physical subscale MD 2.95, 95% CI 0.55 to 5.35; 1 trial, 232 participants; moderate-certainty evidence); or mental health (SF-36 mental subscale MD 3.65, 95% CI 0.52 to 6.78; 1 trial, 232 participants; moderate-certainty evidence); but not on EuroQoL (MD 6.17, 95% CI 1.87 to 10.47; 1 trial, 232 participants; moderate-certainty evidence); or EuroQoL-5D scale (MD 0.02, 95% CI -0.04 to 0.08; 1 trial, 232 participants; moderate-certainty evidence). Adverse effects Compared with sham procedures, corticosteroid implants may slightly increase the risk of cataract formation (RR 2.69, 95% CI 1.17 to 6.18; 1 trial, 90 eyes; low-certainty evidence), but not the risk of cataract progression (RR 2.00, 95% CI 0.65 to 6.12; 1 trial, 117 eyes; low-certainty evidence); or the need for surgery (RR 2.98, 95% CI 0.82 to 10.81; 1 trial, 180 eyes; low-certainty evidence), during up to 12 months of follow-up. These implants may increase the risk of elevated intraocular pressure ([IOP] RR 2.81, 95% CI 1.42 to 5.56; 2 trials, 282 participants; moderate-certainty evidence); and the need for IOP-lowering eyedrops (RR 1.85, 95% CI 1.05 to 3.25; 2 trials, 282 participants; moderate-certainty evidence); but not the need for IOP-lowering surgery (RR 0.72, 95% CI 0.13 to 4.17; 2 trials, 282 participants; moderate-certainty evidence). Evidence comparing the 0.59 mg FA implant with standard-of-care suggested that the implant may increase the risk of cataract progression (RR 2.71, 95% CI 2.06 to 3.56; 2 trials, 210 eyes; low-certainty evidence); and the need for surgery (RR 2.98, 95% CI 2.33 to 3.79; 2 trials, 371 eyes; low-certainty evidence); along with the risk of elevated IOP (RR 3.64, 95% CI 2.71 to 4.87; 2 trials, 605 eyes; moderate-certainty evidence); and the need for medical (RR 3.04, 95% CI 2.36 to 3.91; 2 trials, 544 eyes; moderate-certainty evidence); or surgical interventions (RR 5.43, 95% CI 3.12 to 9.45; 2 trials, 599 eyes; moderate-certainty evidence). In either comparison, these implants did not increase the risk for endophthalmitis, retinal tear, or retinal detachment (moderate-certainty evidence).

Authors' conclusions: Our confidence is limited that local corticosteroid implants are superior to sham therapy or standard-of-care therapy in reducing the risk of uveitis recurrence. We demonstrated different effectiveness on BCVA relative to comparators in people with non-infectious uveitis. Nevertheless, the evidence suggests that these implants may increase the risk of cataract progression and IOP elevation, which will require interventions over time. To better understand the efficacy and safety profiles of corticosteroid implants, we need future trials that examine implants of different doses, used for different durations. The trials should measure core standard outcomes that are universally defined, and measured at comparable follow-up time points.

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Conflict of interest statement

Amit Reddy: no financial disclosures

Su‐Hsun Liu: reports a grant UG1 EY020522 from the National Eye Institute, National Institutes of Health, USA; payment to institution

Christopher J Brady: No financial conflicts of interest

Pamela C Sieving: reports no financial conflicts. She is a special volunteer for the National Eye Institute, National Institutes of Health, USA: this is an unpaid position in which she performs occasional literature searches and analysis of scholarly impact for NEI staff.

Alan G Palestine: serves as a Co‐investigator for Cochrane Eyes and Vision US Satellite, which is support by grant UG1 EY020522 from the National Eye Institute, National Institutes of Health, USA.

Figures

1
1
Flow diagram for study selection for the 2022 update
2
2
Risk of bias summary: review authors' judgments about each risk of bias domain for each trial that reported recurrence of uveitis and BCVA
3
3
Forest plot of comparison 1: Steroid implant versus sham procedure, outcome: 1.1 Proportion of participants with recurrence of uveitis.
4
4
Forest plot of comparison 1: Steroid implant versus sham procedure, outcome: 1.2 Improvement in BCVA in logMAR.
5
5
Forest plot of comparisons 1 and 3, outcome: 2.3 Proportion of participants or eyes that underwent cataract surgery. Trials in comparison 1 and Pavesio 2010 in comparison 3 included one study eye per participant; Kempen 2011 in comparison 3 reported eye‐level outcome data.
6
6
Forest plot of comparisons 1 and 3, outcome: 2.6 Proportion of participants or eyes that underwent IOP‐lowering surgery. Trials in comparison 1 and Pavesio 2010 in comparison 3 included one study eye per participant; Kempen 2011 in comparison 3 reported eye‐level outcome data.
7
7
Forest plot of comparison 3: Steroid implant versus standard‐of‐care, outcome: 3.1 Proportion of eyes with recurrence of uveitis. Pavesio 2010 included one study eye per participant whereas Kempen 2011 included one or two affected eyes into the trial and reported at the eye level.
8
8
Forest plot of comparison 3: Steroid implant versus standard‐of‐care, outcome: 3.3 Improvement in BCVA in logMAR. Pavesio 2010 included one study eye per participant whereas Kempen 2011 included one or two affected eyes into the trial and reported at the eye level.
1.1
1.1. Analysis
Comparison 1: Steroid implant vs sham procedure, Outcome 1: Proportion of participants with recurrence of uveitis
1.2
1.2. Analysis
Comparison 1: Steroid implant vs sham procedure, Outcome 2: Improvement in BCVA [logMAR]
1.3
1.3. Analysis
Comparison 1: Steroid implant vs sham procedure, Outcome 3: Mean difference in quality of life scores
2.1
2.1. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 1: Proportion of eyes with cataract formation
2.2
2.2. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 2: Proportion of eyes with cataract progression
2.3
2.3. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 3: Proportion of eyes that underwent cataract surgery
2.4
2.4. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 4: Proportion of eyes with elevated IOP
2.5
2.5. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 5: Proportion of eyes receiving IOP‐lowering medications
2.6
2.6. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 6: Proportion of eyes that underwent IOP‐lowering surgery
2.7
2.7. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 7: Proportion of eyes with endophthalmitis
2.8
2.8. Analysis
Comparison 2: Steroid implant vs sham procedure: ocular adverse events, Outcome 8: Proportion of eyes with retinal tear or detachment
3.1
3.1. Analysis
Comparison 3: Steroid implant vs standard‐of‐care, Outcome 1: Proportion of eyes with recurrence of uveitis
3.2
3.2. Analysis
Comparison 3: Steroid implant vs standard‐of‐care, Outcome 2: Proportion of eyes with recurrence of uveitis; sensitivity analysis
3.3
3.3. Analysis
Comparison 3: Steroid implant vs standard‐of‐care, Outcome 3: Improvement in BCVA [logMAR]
3.4
3.4. Analysis
Comparison 3: Steroid implant vs standard‐of‐care, Outcome 4: Mean difference in quality of life scores
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    1. CTRI/2014/12/005337. A research to study the effect of fluocinolone acetonide intravitreal (FAi) insert in patients with inflammation of middle layer of the eye. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2014/12/005337 (first registered 30 December 2014).
    1. Cai CX, Skalak C, Keenan RT, Grewal DS, Jaffe GJ. Time to disease recurrence in noninfectious uveitis following long-acting injectable fluocinolone acetonide implant. Graefe's Archive for Clinical and Experimental Ophthalmology 2020;258(5):1023-30. - PubMed
    1. EUCTR2013-001810-14-GB. A clinical study of the FAI insert in patients with uveitis in the back of the eye that is not caused by an infection. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-001810-14-GB (first received 19 August, 2013).
    1. Jaffe GJ, Foster CS, Pavesio CE, Paggiarino DA, Riedel GE. Effect of an injectable fluocinolone acetonide insert on recurrence rates in chronic noninfectious uveitis affecting the posterior segment: twelve-month results. Ophthalmology 2019;126(4):601‐10. - PubMed
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    1. NCT00468871. Safety and efficacy of fluocinolone acetonide intravitreal implant vs standardized therapy. clinicaltrials.gov/show/NCT00468871 (first received 3 May 2007).
    1. Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology 2010;117(3):567-75. - PubMed
    1. Pavesio CE, Bairi K. Evaluation of an intravitreal fluocinolone acetonide implant vs. standard systemic therapy in noninfectious posterior uveitis. American Academy of Ophthalmology 2006:Poster 194. - PubMed

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Acharya 2004 {published data only}
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ACTRN12605000485639 {published data only}
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Arcinue 2013 {published data only}
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Callanan 2008 {published data only}
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References to ongoing studies

ChiCTR1900026160 {published data only}
    1. ChiCTR1900026160. A phase III, multi-center, randomized, double-blind, controlled, safety and efficacy study for a fluocinolone acetonide intravitreal (FAi) insert in subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR1900026160 (first received 24 September 2019).
NCT05070728 {published data only}
    1. NCT05070728. Safety and efficacy of an injectable fluocinolone acetonide intravitreal insert (FAi). clinicaltrials.gov/show/NCT05070728 (first received 6 October 2021).
NCT05101928 {published data only}
    1. NCT05101928. Ozurdex monotherapy trial. clinicaltrials.gov/show/NCT05101928 (first received 21 October 2021).

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References to other published versions of this review

Brady 2013
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