The Oasis Mp-1 Substudy

Sadda, Srinivas R; González, Víctor H.; Meunier, Esmeralda; Kozma, Petra

doi:10.1097/iae.0000000000001982

Cited by 3 publications

(2 citation statements)

References 27 publications

(37 reference statements)

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“…Previously, we reported on a substudy of subjects from the OASIS trial who underwent MP to better understand the impact on visual function. 9 This MP sub study only included 27 subjects, but demonstrated a consistently better sensitivity in ocriplasmin treatment patients. However, a transient reduction in sensitivity in the ocriplasmin group was noted at week 1 and month 1.…”

Section: Discussionmentioning

confidence: 99%

“…These findings are very much in line with previously reported electrophysiologic and microperimetric findings. 9 Our study is not without limitations, including most notably the loss of subjects over time which was by virtue of the design of the study which permitted subjects who did not experience release of traction to be exited and undergo vitrectomy or other procedures per their treating physician. The loss of subjects was especially problematic in the sham group where most patients did not demonstrate a spontaneous release.…”

Section: Discussionmentioning

confidence: 99%

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Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

Velaga

Nittala

et al. 2021

BMJ Open Ophth

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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

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

Velaga

Nittala

et al. 2021

BMJ Open Ophth

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Multimodal imaging of macular subretinal deposits following intravitreal ocriplasmin injection

Chow¹,

Hong²,

Chang³

2018

American Journal of Ophthalmology Case Reports

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PurposeOcriplasmin is effective in closing macular holes due to vitreomacular traction. We present a case of macular subretinal material deposition observed with spectral-domain optical coherence tomography (SD-OCT) and multimodal imaging, following successful closure of a macular hole following intravitreal ocriplasmin injection.ObservationsAn 81-year-old male presented with decreased vision in the left eye due to a full-thickness macular hole secondary to vitreomacular traction. Ocriplasmin (Jetrea) was injected into the vitreous and hole closure was observed after one week. Macular subretinal material deposition developed along the outer surface of the resultant serous detachment on OCT one week post-injection. Fluorescein angiography demonstrated no expanding hyperfluorescence due to retinal or choroidal leak, or staining of the lesion. The material was mildly autofluorescent. The macular subretinal material complex spontaneously decreased with no significant effect on vision over 60 weeks.Conclusions and importanceMacular subretinal material deposition has not previously been reported following intravitreal ocriplasmin injection. This material is likely composed of photoreceptor outer segments. It is important to recognize that macular subretinal deposits can occur following intravitreal ocriplasmin injection as it may cause diagnostic confusion and potentially influence the visual and anatomical outcomes following successful hole closure.

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Visual functional changes after ocriplasmin injection for vitreomacular traction: A microperimetric analysis

Furino

Niro²,

Sborgia

et al. 2021

Taiwan J Ophthalmol

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PURPOSE: The purpose is to evaluate functional changes after ocriplasmin injection to treat vitreomacular traction (VMT) by microperimetry. MATERIALS AND METHODS: Prospective interventional study on patients underwent an intravitreal ocriplasmin injection. Optical coherence tomography, best-corrected visual acuity (BCVA) test, and microperimetry were performed at baseline, 1 week, 1 and 3 months. Microperimeter recorded retinal sensitivity (RS) and central retinal sensitivity (CRS) at central 12° and 4°, respectively, and fixation as bivariate contour ellipse area (BCEA) at 68%, 95%, and 99% of fixation points. Functional parameters were analyzed in patients who had (Group A) or not (Group B) VMT release. RESULTS: Twenty-one patients including 18 with VMT and 3 with VMT plus macular hole (MH) were treated. Eleven patients achieved VMT resolution including all cases with MH that achieved hole closure. An impairment of BCVA, RS and CRS ( P < 0.01; P < 0.001; P = 0.001, respectively) was reported at 1 week followed by a significant improvement (BCVA, P = 0.001; RS, CRS, P = 0.02) at 3 months. The early impairment of visual acuity and sensitivity significantly occurred in Group B ( P ≤ 0.01) while their recovery significantly occurred in Group A ( P < 0.01). BCEA significantly increased in dimension (68%, P = 0.01; 95%, P = 0.03) at 1 week, subsequently returning to near baseline values over follow-up. Only in Group A, fixation stability significantly improved at 3 months. CONCLUSION: Microperimetry confirms an early and reversible functional impairment after ocriplasmin injection regardless VMT resolution. If a greater decrease in function could occur in the eyes without VMT resolution, a better functional recovery could occur in the event of VMT resolution.

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The Oasis Mp-1 Substudy

Cited by 3 publications

References 27 publications

Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

Multimodal imaging of macular subretinal deposits following intravitreal ocriplasmin injection

Visual functional changes after ocriplasmin injection for vitreomacular traction: A microperimetric analysis

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