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Ocriplasmin for symptomatic vitreomacular adhesion: an evidence-based review of its potential.

ABSTRACT: Vitreomacular traction is a multicategory entity that may cause substantial visual loss due to the formation of a macular hole or traction-induced tissue distortion. The advent of optical coherent tomography (OCT) has demonstrated the anatomic features of persistent vitreomacular attachment (VMA) more definitively, including in many asymptomatic or minimally symptomatic patients. The indications for intervention are unclear, since it is not possible to predict which eyes might be likely to develop progressive visual loss. This has been especially important since for many years, the only treatment option involved surgical intervention (vitrectomy) to release the persistent VMA. Recently, a pharmacolytic agent, ocriplasmin, has become available after many years of development and investigation, and may offer a feasible alternative to surgery, or even a risk/benefit ratio sufficiently favorable to offer intervention at an earlier stage of VMA. Several studies, including a large, prospective clinical trial, have established the foundation of its rationale and efficacy, providing the basis of its approval. The role for ocriplasmin in clinical practice is in the process of being determined. This paper summarizes current knowledge and status of investigations regarding ocriplasmin-induced pharmacologic vitreolysis, and offers some evidence-based considerations for its use.

SUBMITTER: Song SJ

PROVIDER: S-EPMC3968080 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Ocriplasmin for symptomatic vitreomacular adhesion: an evidence-based review of its potential.

Song Su Jeong SJ Smiddy William E WE

Core evidence 20140321

Vitreomacular traction is a multicategory entity that may cause substantial visual loss due to the formation of a macular hole or traction-induced tissue distortion. The advent of optical coherent tomography (OCT) has demonstrated the anatomic features of persistent vitreomacular attachment (VMA) more definitively, including in many asymptomatic or minimally symptomatic patients. The indications for intervention are unclear, since it is not possible to predict which eyes might be likely to devel ...[more]

PMID: 24711777

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Project description:Background/aimsOASIS is a Phase IIIb trial (NCT01429441) assessing long-term outcomes in subjects with symptomatic vitreomacular adhesion (VMA). The purpose of this study is to report on the frequency, severity, location and time course of ellipsoid zone (EZ) alterations in ocriplasmin-treated and sham control eyes in the OASIS study.Methods220 patients (146 ocriplasmin, 74 sham) subjects with VMA were enrolled in this masked post hoc analysis phase IIIb, randomised, sham-controlled double-masked multicentre clinical trial. A masked post hoc analysis of OCT images was performed at the Doheny Image Reading Center from subjects enrolled in the OASIS trial. The status of the EZ band was assessed in three different macular regions: the central subfield (CS) (≤1 mm diameter), the parafoveal area (PAA) (>1 to ≤3 mm) and the perifoveal area (PEA) (>3 to ≤6 mm). The EZ band was rated as normal/intact, full thickness macular hole (FTMH), abnormal but continuous, discontinuous/disrupted or absent at visits from baseline (pretreatment) to week 1 (day 7), month 1 (day 28), month 3, month 6, month 12 and the final follow-up at month 24. EZ band status was compared in both study and control eyes.ResultsA total of 208 patients (138 ocriplasmin, 70 sham) were included in this analysis. At baseline, FTMH was present in 48.6%, 8.0%, 0% and 52.8%, 2.9%, 0% in the CS, PAA and PEA of the ocriplasmin and sham groups, respectively. The EZ was graded to be abnormal but continuous, discontinuous/disrupted or absent at Baseline in 21.0%, 4.3%, 2.8% in the CS, PAA and PEA, respectively, of the ocriplasmin group; and 12.9%, 10.0%, 4.3% in the CS, PAA and PEA of the sham group. For the ocriplasmin group in the PAA, this frequency increased to 6.6% at week 1, was 9.8% at month 1, but improved to 3.8% at month 3, and remained stable to 1.6% at month 24. These differences, however, were not statistically significant.ConclusionsOcriplasmin treatment for symptomatic VMA was associated with EZ abnormalities in a small percentage of patients that was best assessed in regions (PEA) relatively unaffected by the VM interface disease at baseline. The EZ abnormalities were apparent by week 1, persisted at month 1, and appeared to resolve in the majority of cases by month 3.Trial registration numberNCT01429441.

Project description:BackgroundSD-OCT is becoming commonplace in everyday practice. Vitreomacular adhesions (VMAs) are being more routinely diagnosed. Predictive studies to the natural course of VMA are thus clinically significant. Spectral domain-optical coherence tomography (SD-OCT) was presently utilized to analyze the incidence of floaters, the complete vitreomacular separation or VMA, the VMA complication, the vitreomacular angle (VMAng), and the complication mechanism.MethodsMonthly SD-OCT was performed on patients with/without symptomatic floaters. OCT allowed VMA and vitreomacular separation to be compared. The incidence was assessed applying one-tailed Fisher's exact tests. The VMAngs between the inner retina and posterior hyaloid were measured, and the complication mechanism was studied using OCT image. For macular hole (MH), pre- and/or post-operative best corrected visual acuities (BCVAs; LogMAR), refractions and photoreceptor conditions were also evaluated.ResultsTotally, 124 eyes were included; there were 116 eyes with VMA and 8 eyes with vitreomacular separation. Considering the percentages over 124 eyes, floaters were present in 14.5% of enrolled eyes (=18/124), consisting of 12.9% of eyes with VMA (16/124) and 1.6% of eyes with vitreomacular separation (2/124). Moreover, there were twelve eyes (9.7%) with VMA-associated vision-threatening complications, including MH (n = 8; 6.5%), retinal detachment (RD; n = 2; 1.6%), vitreomacular traction (VMT; n = 1; 0.8%) and macular pucker (MP; n = 1; 0.8%). Eyes with initial VMA had a significantly greater possibility of complications than eyes with initial vitreomacular separation (p = 0.03). Among these eyes with MH (n = 8), the pre-operative BCVA (LogMAR) was 1.1 ± 0.5, which was insignificantly (p = 0.35) improved to 0.8 ± 0.7 post-operatively. The VMAng of VMA eyes with MHs was 24.2 ± 24.9° (n = 8). The critical VMAng was 13.3°.ConclusionsA minority of eyes with VMA or vitreomacular separation had floaters. Moreover, the use of SD-OCT could identify vision-threatening sequelae, namely MH, RD, MP and VMT, and this was significantly more frequent in eyes with VMA than in eyes with complete vitreomacular separation. Therefore, SD-OCT might be a useful way of identifying either identity, and evaluating VMA-associated complications. Whether VMA eyes with MH (n = 8) that have a VMAng greater than critical VMAng have a greater likelihood of tangential traction and subsequent MH needs further investigation.

Project description:Importance:While symptomatic vitreomacular interface abnormalities (VIAs) are common, assessment of vision preference values and treatment preferences of these may guide treatment recommendations by physicians and influence third-party payers. Objective:To determine preference values that individuals with VIA assign to their visual state and preferences of potential treatments. Design, Setting, and Participants:In this cross-sectional one-time questionnaire study conducted between December 2015 and January 2017, 213 patients from tertiary care referral centers in Thailand, the United Kingdom, and the United States were studied. Patients with symptomatic VIA diagnosed within 1 year of data collection, visual acuity less than 20/20 OU, and symptoms ascribed to VIAs were included. Data were analyzed from January 2017 to November 2017. Main Outcomes and Measures:The primary end points were overall mean preference value that individuals with VIA assigned to their visual state and patients' preferences for potential treatments. Preference values were graded on a scale from 0 to 1, with 0 indicating death and 1 indicating perfect health with perfect vision. Results:Of the 213 included patients, 139 (65.3%) were women, and the mean (SD) age was 65.6 (7.7) years. Diagnoses included epiretinal membrane (n = 100 [46.9%]), macular hole (n = 99 [46.5%]), and vitreomacular traction (n = 14 [6.6%]). The mean (SD) vision preference value was 0.76 (0.15), without differences identified among the 3 VIA types. More participants were enthusiastic about vitrectomy (150 [71.1%]) compared with intravitreal injection (120 [56.9%]) (difference, 14.2%; 95% CI, 5.16-23.3; P = .002). Adjusted analyses showed enthusiasm for vitrectomy was associated with fellow eye visual acuity (odds ratio, 10.99; 95% CI, 2.01-59.97; P = .006) and better-seeing eye visual acuity (odds ratio, 0.03; 95% CI, 0.001-0.66; P = .03). Overall enthusiasm for treatment was associated with fellow eye visual acuity (odds ratio, 7.22; 95% CI, 1.29-40.40; P = .02). Overall, most participants (171 [81.0%]) were enthusiastic about surgery, injection, or both. Conclusions and Relevance:Study participants reported similar preference values among 3 types of VIAs. The data suggest that most patients with these conditions would be enthusiastic about undergoing vitrectomy or an injection to treat it, likely because of the condition's effect on visual functioning, although there may be a slight preference for vitrectomy at this time.

Project description:PurposeTo evaluate the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with non-infectious uveitis.DesignPhase 2 clinical trial PARTICIPANTS: Data from the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-infectious Uveitis (STOP-Uveitis) study was analyzed.MethodsIn the STOP-Uveitis study, patients with non-infectious uveitis (NIU) received monthly intravenous infusions of either 4 or 8 mg/kg tocilizumab until month 6 (M6). Spectral domain optical coherence tomography (SD-OCT) images of patients that completed M6 of the study were analyzed at baseline to stratify the patients by the presence (VMA+) or absence (VMA-) of VMA. Patients with vitreomacular traction (VMT) or epiretinal membrane causing structural abnormalities within center 1 mm were excluded. All images were graded by two independent graders.Main outcome measuresMean change in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and vitreous haze (VH) at M6.ResultsOut of 37 patients randomized in the STOP-Uveitis study, 48 eyes (27 patients) were eligible based on the study criteria. At baseline, 19 eyes were classified as VMA+, and 32 eyes were classified as VMA-. The distribution of two doses of TCZ (4 mg/kg and 8 mg/kg) were similar between the two groups. At M6, the mean improvement in BCVA was 2.00 ± 5.3 and 6.50 ± 7.98 letters in the VMA+ and VMA- groups, respectively (p = 0.02). The mean improvement in CRT was 34.85 ± 72.36 and 80.37 ± 157.21 μm in the VMA+ and VMA- groups, respectively (p = 0.18). Similarly, the mean change in VH was - 0.65 ± 0.47 and - 0.76 ± 0.71 in the VMA+ and VMA- groups, respectively (p = 0.32). Out of 16 eyes with VMA at baseline, 3 eyes developed posterior vitreous detachment (PVD) at M6. The mean change in BCVA was significantly higher (p = 0.02), while CRT and VH score were similar (p > 0.05) in eyes with PVD compared to eyes with persistent VMA.ConclusionsThe absence of VMA or development of PVD in eyes with VMA seems to have a beneficial effect on the vision of subjects receiving treatment for uveitis. Therefore, patients with uveitis should be assessed using SD-OCT for the presence of vitreomacular interface abnormalities.

Dataset Information

Ocriplasmin for symptomatic vitreomacular adhesion: an evidence-based review of its potential.

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Ocriplasmin for symptomatic vitreomacular adhesion: an evidence-based review of its potential.

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