The 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: Intraocular Pressure-Related Effects over 36 Months.

PURPOSE: To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME). DESIGN: Secondary analysis of a 36-month, phase IV, nonrandomized, open-label, observational study. PARTICIPANTS: The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication. METHODS: Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant. RESULTS: Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan-Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable. CONCLUSIONS: Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Reduced Incidence of Intravitreal Injection-Related Endophthalmitis With Prefilled Syringes.

Purpose: To evaluate the incidence and clinical characteristics of intravitreal injection-related endophthalmitis cases with antivascular endothelial growth factor (anti-VEGF) medications manufactured as prefilled syringes or non-prefilled preparations. Methods: This retrospective chart review comprised eyes that received intravitreal anti-VEGF at a single-specialty retina practice from January 1, 2014, to December 31, 2019. Eyes diagnosed with injection-related endophthalmitis were identified. Demographic and clinical data were abstracted from medical records, including the type of anti-VEGF agent, baseline and follow-up corrected visual acuity (VA), and microbiologic findings. Results: The review identified 88 cases of intravitreal anti-VEGF injection-related endophthalmitis and 325 990 total injections. Total injections included 32 045 (9.8%) bevacizumab (BEV), 93 073 (28.6%) ranibizumab (RAN), 122 947 (37.7%) aflibercept (AFL), and 77 925 (23.9%) ranibizumab prefilled syringe (RANPFS). Ten of the endophthalmitis cases were related to BEV, 21 to RAN, 45 to AFL, and 12 to RANPFS. The endophthalmitis rate was lowest for RANPFS (0.0154%) (BEV, 0.0312%; RAN, 0.0226%; AFL, 0.0366%) (P = .030). Thirty-four (41.5%) of 82 samples were culture positive. RANPFS had a significantly lower rate of culture-proven postinjection endophthalmitis than the other agents (P = .003). The mean VA for endophthalmitis cases related to RANPFS vs non-prefilled agents was similar at presentation (Snellen 20/2092 vs 20/2327) and at the 3-month follow-up (Snellen 20/201 vs 20/272) (both P > .05). Conclusions: Anti-VEGF medications in prefilled syringes may reduce the risk for medication contamination during injection preparation. RANPFS was associated with a lower rate of injection-related endophthalmitis than non-prefilled anti-VEGF medications.

Ganglion Cell Layer Thickness Change in Neovascular Age-Related Macular Degeneration Treated With Anti-VEGF Injections.

Purpose: This work assesses bilateral ganglion cell layer-inner plexiform layer (GCL-IPL) thickness changes in patients with unilateral neovascular age-related macular degeneration (nAMD) treated with antivascular endothelial growth factor (anti-VEGF). Methods: In this single-center, retrospective, cohort study, the medical records of patients with unilateral nAMD treated with anti-VEGF were reviewed. The treated group included eyes with newly diagnosed nAMD that subsequently underwent treatment with intravitreal anti-VEGF injections. The control group was the fellow eye with dry AMD. Eyes receiving at least 10 intravitreal injections were included. Measurement of GCL-IPL thickness was performed at different time points using spectral domain-optical coherence tomography. Results: A total of 216 eyes of 108 patients met the inclusion criteria. The mean age ± SD was 80.1 ± 10.7 years. Eyes in the treated group underwent a mean ± SD of 20.2 ± 7.2 injections in 21.3 ± 6.8 months. At baseline, average mean ± SD of GCL-IPL thickness was 73.71 ± 8.81 µm and 73.84 ± 8.26 µm in the treated and fellow eye, respectively (P = .795). After 10 injections the average thickness was 65.41 ± 14.08 µm and 68.77 ± 13.24 µm in the treated and fellow eye, respectively (P = .007). The absolute decrease in thickness was significantly greater in the treated eye than the fellow eye (mean ± SD, 8.31 ± 11.19 µm vs 5.07 ± 10.83 µm, respectively; P = .002). Conclusions: GCL-IPL thickness decreased significantly in the treated group more than in the control group after 10 anti-VEGF injections. The mechanism and clinical significance of this observation warrants further study.

Scleral Buckle Removal: Indications, Timing, Complications, and Long-Term Outcomes.

BACKGROUND AND OBJECTIVE: To report indications, timing, complications, and outcomes of scleral buckle (SB) removal surgery. PATIENTS AND METHODS: Retrospective observational case series. Eyes that underwent SB removal between 2010 and 2016 with greater than 1 year of follow-up were included. Main outcome measures were post-SB removal complications and best-corrected visual acuity (BCVA). RESULTS: Fifty eyes that underwent SB removal met the inclusion criteria. Indications include exposed SB (54%), infection (26%), diplopia (16%), and recurrent retinal detachment (4%). Mean and median intervals between SB placement and removal were 65 months and 30 months. Complications include recurrent retinal detachment (12%), transient ocular hypertension (6%), and persistent diplopia (4%). There was no significant change in mean BCVA after SB removal (P = .979). CONCLUSIONS: Exposed SB, infection, and diplopia are the most common indications for SB removal. The single-surgery success rate is high and the risk for complications is relatively low. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:138-144.].

Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study.

BACKGROUND: The 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO. METHODS: This 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured. RESULTS: Data were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1-3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041). CONCLUSION: Few IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge. TRIAL REGISTRATION NUMBER: NCT02424019.

THE EFFECT OF ELECTIVE CATARACT EXTRACTION BY PHACOEMULSIFICATION IN EYES WITH VITREOMACULAR TRACTION SYNDROME.

PURPOSE: To evaluate the effect of cataract extraction (CE) by phacoemulsification on the vitreomacular interface (VMI) of eyes with preexisting vitreomacular traction (VMT). METHODS: Retrospective, observational case series. Patients with VMT who elected to proceed with CE, before any vitreoretinal intervention, were studied. Eyes with at least a 12-month follow-up period were included. The status of the vitreomacular adhesion at different time points was assessed using spectral-domain optical coherence tomography. The best-corrected visual acuity was recorded at different time points. Other macular and systemic comorbidities were documented. RESULTS: Fifteen eyes from 15 phakic patients with symptomatic VMT were included. Six of them were male subjects. Seven patients had diabetes mellitus and two of them also had nonproliferative diabetic retinopathy. The preoperative macular comorbidities included macular hole in six eyes (Stage 1 in 3 eyes and Stage 2 or 3 in another 3 eyes), epiretinal membrane in five eyes, and cystoid macular edema in four eyes. After uncomplicated CE, the VMT was released in 5 eyes, whereas in 10 eyes, CE did not significantly change the status of the vitreomacular adhesion. Three of 3 eyes with preexisting full-thickness macular hole (Stage 2 or 3 macular hole) were found to have Stage 4 macular hole shortly after CE. In seven of seven patients with diabetes mellitus, the status of the vitreomacular interface did not change after CE. Eventually, 7 of 15 patients underwent additional pars plana vitrectomy. Compared with the baseline vision, and vision before other interventions, the visual acuity after CE improved in 5 patients, remained unchanged in 7 patients, and decreased in the 3 patients with Stage 2 or 3 macular hole. The mean preoperative and early postoperative visual acuity was 20/59 and 20/68, respectively (P > 0.05). CONCLUSION: The effect of CE in phakic eyes with known VMT varies significantly. In the current case series, every eye with VMT and Stage 2 or 3 macular hole ended up with Stage 4 macular hole, although the VMT did not change significantly in the eyes of diabetic patients. Studies with larger sample size are needed to further elucidate the impact of elective CE on VMT.

Optimizing DME Treatment With Decreased Injection Frequency Using Long-Term Steroid Implants.

BACKGROUND AND OBJECTIVE: Anti-vascular endothelial growth factor (VEGF) agents are the first-line treatment for diabetic macular edema (DME) based on randomized, control trials from the early 2000s. However, the efficacy of anti-VEGF is limited in clinical practice because its monthly injection schedule is logistically challenging for most working-age patients. PATIENTS AND METHODS: Recent large-scale, randomized, control trials have demonstrated that intravitreal corticosteroid implants provide efficacious long-term treatment for DME. RESULTS: Intravitreal corticosteroid implants block a wide spectrum of inflammatory factors involved in DME pathogenesis, with each implant lasting from months to years. Intravitreal corticosteroid implants also have the pharmacokinetic advantage over anti-VEGF agents in vitrectomized eyes. CONCLUSIONS: Although anti-VEGF agents have lower bioavailability in vitrectomized eyes due to rapid clearance, intravitreal corticosteroid implants are not significantly affected by vitrectomy in bioavailability or efficacy. Side effects of intravitreal corticosteroid implants include cataract formation and ocular hypertension, both of which are manageable with appropriate monitoring. Taken together, intravitreal corticosteroid implants serve as a convenient, efficacious, and long-term treatment for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:S22-S29.].

RELENTLESS PLACOID CHORIORETINITIS: SUCCESSFUL LONG-TERM TREATMENT WITH INTRAVITREAL TRIAMCINOLONE.

PURPOSE: To report a case of relentless placoid chorioretinitis (ampiginous choroiditis) treated with intravitreal triamcinolone acetonide (IVTA). METHODS: Interventional case report. RESULTS: A 34-year-old pregnant woman with a history of poor visual acuity in her left eye, secondary to an undetermined cause, developed an acute painless central scotoma and blurred vision in the right eye. The examination revealed decreased visual acuity, active inflammatory placoid choroidal lesions in the posterior pole, and mid-periphery with sharp disk margins and normal-appearing vasculature. A diagnosis of relentless placoid chorioretinitis was made, and the patient was treated biannually with 4 mg IVTA for 3 years with visual improvement to 20/25. Although she experienced a relapse at 12 months, the episode was adequately controlled with repeat IVTA. After the sixth IVTA treatment occurring at 30 months, the decision was made to stop IVTA, ultimately facilitating the preservation of 20/25 in the right eye at 63-month follow-up. The disease course was complicated by cataract progression that was successfully treated with a cataract extraction and episodic increases in intraocular pressure which were successfully treated with timolol ophthalmic solution. CONCLUSION: Intravitreal triamcinolone acetonide therapy represents an important alternative in the treatment of relentless placoid chorioretinitis. By avoiding the potentially significant side effects of long-term systemic corticosteroid and immunosuppressive therapies, IVTA can be an important alternative in the long-term management of this uncommon and complicated entity.

CLINICAL FINDINGS IN TRIAMCINOLONE-ASSOCIATED MACULOPATHY.

PURPOSE: To describe a crystalline retinopathy observed in patients greater than 1 year after intravitreal injection of triamcinolone acetonide (IVTA). METHODS: A retrospective, interventional, noncomparative, single-center case series of patients who received IVTA and developed subsequent crystalline retinopathy lasting greater than 1 year after injection. RESULTS: Eighteen eyes of 16 patients in which preretinal crystals were observed >1 year after IVTA were included in the study, with a mean follow-up (range) of 5.8 years (1.1-9.2) after IVTA. The crystals were refractile, not visible on fluorescein nor indocyanine green angiography, exhibited slow dissolution and movement, and were occasionally distributed in a circular fashion. Optical coherence tomography confirmed the preretinal and/or subhyaloid location of crystals. CONCLUSION: Macular crystals can persist for years after IVTA. The crystals localize to the preretinal or subhyaloid space, are angiographically silent, can exhibit slow dissolution and movement, may be distributed in a circular fashion reflecting the bursa premacularis, and appear nonpathologic.

INTRAVITREAL OCRIPLASMIN IN CLINICAL PRACTICE: Predictors of Success, Visual Outcomes, and Complications.

PURPOSE: To investigate predictors of success, visual outcomes, and complications of intravitreal ocriplasmin for the treatment of symptomatic vitreomacular adhesion in a clinical care setting. METHODS: Retrospective chart review of 49 consecutive eyes of 47 patients who received intravitreal ocriplasmin. Spectral domain optical coherence tomography scans were examined for vitreomacular traction (VMT) release, full-thickness macular hole (FTMH) closure, and other changes in retinal anatomy. RESULTS: Pharmacologic VMT release occurred in 41% of eyes; positive predictors included age ≤75 years (P = 0.001), phakic status (P = 0.016), VMT width ≤750 µm (P = 0.001), and absence of retinal comorbidities (P = 0.035). Pharmacologic FTMH closure occurred in 25% of cases; positive predictors included successful VMT release (P = 0.042), better preinjection best-corrected visual acuity (P = 0.036), and smaller FTMH aperture width (P = 0.033). Eyes that achieved VMT release and did not undergo surgery attained significant improvement in best-corrected visual acuity (P = 0.015). Complications included subfoveal lucency (33%), ellipsoid zone disruption (33%), and FTMH base enlargement (75%). Only FTMH base enlargement resulted in worse visual outcomes (P = 0.024). Subgroup analysis of 14 eyes with ideal characteristics (all positive predictors listed above) yielded a 93% VMT release rate. CONCLUSION: Proper case selection may facilitate successful pharmacologic vitreolysis with ocriplasmin, improve visual outcomes, and minimize potential complications.

Impact of Baseline Characteristics on Treatment Response to Intravitreal Aflibercept Injection for Wet Age-Related Macular Degeneration.

PURPOSE: To determine whether wet age-related macular degeneration (AMD) treatment outcomes within prespecified patient subgroups were consistent with overall study results. Additionally, this subanalysis investigated whether there were any relationships between baseline characteristics and evaluated treatment outcomes. DESIGN: Post hoc subanalysis of The VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2, 2 similarly designed prospective, multicenter, double-masked, active-controlled, parallel-group, randomized clinical trials. PARTICIPANTS: Two thousand four hundred twelve patients with an active subfoveal choroidal neovascularization (CNV) lesion of any subtype secondary to AMD. METHODS: Primary and key secondary visual end points at week 52 were examined to explore the consistency of effect among prespecified subgroups of 5 baseline characteristics: age, best-corrected visual acuity (BCVA), lesion type, lesion size, and central retinal thickness (CRT). Additionally, within-group analyses were conducted to determine whether the mean changes in BCVA and CRT at 52 weeks were associated positively or negatively with the baseline characteristics of interest. MAIN OUTCOME MEASURES: Consistency of treatment outcomes among prespecified subgroups of baseline characteristics. RESULTS: For each baseline characteristic, tests for interaction within each prespecified subgroup and among the subgroups were not significant, suggesting that relative visual outcomes for each treatment arm were consistent with overall study outcomes. Within-group analysis revealed a significant association between baseline age, BCVA, and lesion size with BCVA outcomes at 52 weeks; namely, older age, greater BCVA, and larger lesion size were associated with lower mean BCVA gains at 52 weeks. CONCLUSIONS: Patients in all subgroups of baseline age, BCVA, lesion type, lesion size, and CRT experienced visual outcomes consistent with those of the overall study population. Additionally, baseline older age, better BCVA, and larger CNV lesion size were found to be associated independently with lower mean BCVA gains after 52 weeks of anti-vascular endothelial growth factor therapy. The influence of baseline age, BCVA, and CNV lesion size on treatment outcomes is consistent with other reports from large, prospective trials in wet AMD.

Ranibizumab Induces Regression of Diabetic Retinopathy in Most Patients at High Risk of Progression to Proliferative Diabetic Retinopathy.

PURPOSE: To evaluate diabetic retinopathy (DR) outcomes with ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) treatment in patients with DR and diabetic macular edema (DME) at high risk of progression to proliferative disease. DESIGN: Post hoc analysis of the phase 3 RIDE (ClinicalTrials.gov identifier, NCT00473382) and RISE (ClinicalTrials.gov identifier, NCT00473330) clinical trials of ranibizumab for the treatment of DME. PARTICIPANTS: Seven hundred forty-six patients with baseline fundus photographs and randomized for treatment. METHODS: Diabetic retinopathy outcomes were assessed through month 36 by baseline DR severity level. Diabetic retinopathy severity was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS). MAIN OUTCOME MEASURES: Two-step or more or 3-step or more improvement or worsening on the ETDRS DRSS and time to new proliferative event (composite end point). RESULTS: At baseline, most patients were distributed evenly among mild or moderate nonproliferative DR (NPDR; ETDRS DRSS, 35/43), moderately severe or severe NPDR (ETDRS DRSS, 47/53), and proliferative DR (ETDRS DRSS, 60-75; 28.8%, 33.2%, and 31.1%, respectively). At month 24, rates of 2-step or more improvement with ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham treatment were highest among patients with baseline DR levels 47/53 (78.4%, 81.1%, and 11.6%, respectively) compared with patients with baseline DR levels 35/43 (10.3%, 15.8%, and 1.4%, respectively) or 60 through 75 without panretinal photocoagulation (31.0%, 36.4%, and 6.7%, respectively; all ranibizumab vs. sham comparisons, P < 0.05). In patients with baseline DR levels 47/53, ranibizumab treatment reduced the probability of patients experiencing a new proliferative event at month 36 by 3 times compared with sham treatment (12.4% and 11.9% vs. 35.2% for ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham, respectively). In patients with baseline DR levels 47/53 who achieved 2-step or more DR improvement, improvements were independent of all assessed baseline characteristics (P > 0.4). CONCLUSIONS: Ranibizumab treatment resulted in DR improvements in all 3 baseline DR severity subsets examined. The greatest benefits in DR improvement occurred in patients with baseline moderately severe to severe NPDR (DR levels 47/53). Diabetic retinopathy improvements were rapid, clinically meaningful, and sustained through month 36.

The Impact of Electronic Reading Devices on Reading Speed and Comfort in Patients with Decreased Vision.

Background/Aims. To evaluate the impact of back-illuminated and nonilluminated electronic reading devices on reading speed and comfort in patients with decreased vision. Methods. A prospective study involving a convenience sample of 167 patients at a single retina practice from January 2011 to December 2012. Participants were asked to read five different excerpts on five different media in a randomly assigned order. Media included a printed book at 12-point font (12PF), iPad2 at 12PF, iPad2 at 18-point font (18PF), Kindle2 at 12PF, and Kindle2 at 18PF. Reading speed in words per minute (WPM) and medium preference were recorded and stratified by visual acuity (VA). Results. Mean reading speeds in WPM: iPad2 at 18PF (217.0), iPad2 at 12PF (209.1), Kindle2 at 18PF (183.3), Kindle2 at 12PF (177.7), and printed book at 12PF (176.8). Reading speed was faster on back-illuminated media compared to nonilluminated media. Text magnification minimized losses in reading performance with worsening patient VA. The majority of participants preferred reading on the iPad2 at 18PF. Conclusions. Back-illuminated devices may increase reading speed and comfort relative to nonilluminated devices and printed text, particularly in patients with decreased VA.

Macula Society Collaborative Retrospective Study of Ocriplasmin for Symptomatic Vitreomacular Adhesion.

PURPOSE: To assess anatomic and visual outcomes of ocriplasmin use for symptomatic vitreomacular adhesion (VMA). DESIGN: Retrospective chart review. METHODS: Macula Society members were surveyed online to collect data on ocriplasmin for symptomatic VMA. Clinical and optical coherence tomography data were collected using standardized data entry forms. RESULTS: There were 208 patients (208 eyes) with symptomatic VMA followed at least 3 weeks after receiving ocriplasmin. At baseline, VMA was focal (<1500 µm) in 179 eyes (86%), broad in 9 eyes (4%), and not reported in 20 eyes (10%). A full-thickness macular hole (MH) was present in 75 eyes (36%); size was <400 µm in 62 eyes (82%). Baseline mean visual acuity was approximately 20/63. Of the 204 eyes with ≥12 weeks follow-up, pars plana vitrectomy (PPVx) was performed in 12 (6%) by 4 weeks, 31 (15%) by 12 weeks, and 64 (31%) by the last visit. VMA had resolved by 12 weeks with ocriplasmin alone in 83 of 191 eyes (43%) by week 12 and in 148 of 200 eyes (74%) by the last visit, including eyes undergoing PPVx. Among eyes with a baseline MH, closure was achieved with ocriplasmin alone in 10 of 65 (15%) by 1 week, 26 of 74 (35%) by 4 weeks, and 30 of 75 (40%) at the last visit. Mean change in visual acuity at the last visit compared with baseline was -0.06±0.40 logarithm of the minimum angle of resolution (logMAR) (modest vision improvement) (P = 0.03). At the last visit, visual acuity improved by ≥2 lines in 69 eyes (35%) and by ≥3 lines in 54 eyes (27%). Visual acuity decreased ≥2 lines in 35 eyes (18%) and by 3 lines in 27 eyes (14%) at the final visit. Complications included photopsias (15%), dimness of vision (14%), decreased color vision (10%), MH development (5%), macular retinal pigment epithelium atrophy (2.7%), retinal detachment (1.9%), and retinal tear (1.4%). No endophthalmitis cases were reported. CONCLUSIONS: Physician-reported outcomes on ocriplasmin use confirmed VMA release in 45% and closure of MH in 40% of eyes without PPVx. Visual acuity decreased in approximately 20% of eyes. Adverse events were not infrequent and suggest caution when considering ocriplasmin use.

Retina Specialists Treating Diabetic Macular Edema Recommend Different Approaches for Patients Than They Would Choose for Themselves.

BACKGROUND AND OBJECTIVE: Prior investigation shows retina specialists may select different treatment for age-related macular degeneration for themselves than for a hypothetical patient. The authors sought to investigate whether a similar bias exists for treatment decisions by retina specialists with regard to diabetic macular edema (DME). PATIENTS AND METHODS: Two surveys asked retina specialists to select treatment for hypothetical patients with DME or for themselves. In Survey 2, a distinction was drawn between a visual acuity (VA) of 20/40 or better and 20/50 or worse. RESULTS: In Survey 1, 54% to 61% of respondents selected bevacizumab (Avastin; Genentech, South San Francisco, CA) for patients and 36% to 40% selected the drug for themselves (P < .0004). It was found that 14% to 17% selected aflibercept (Eylea; Regeneron, Tarrytown, NY) for patients versus 31% to 38% who selected it for themselves (P < .0001). For a VA of 20/40 or better, 42% to 50% selected bevacizumab for their patients versus 32% to 39% (P < .0005) for themselves, and 20% to 23% selected aflibercept for patients versus 39% to 48% (P < .0007) for themselves. For a VA of 20/50 or worse, 24% to 28% chose bevacizumab for patients versus 17% to 20% for themselves (P value was not significant), and 59% to 66% selected aflibercept for their patients versus 66% to 78% for themselves (P < .05). CONCLUSION: Physicians recommend different treatment for their patients than for themselves, though not for a VA of 20/50 or worse, where data support the use of aflibercept over bevacizumab. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:544-554.].

Post-Marketing Survey of Adverse Events Following Ocriplasmin.

BACKGROUND AND OBJECTIVE: To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States. STUDY DESIGN/MATERIALS AND METHODS: Two thousand four hundred sixty-five retinal physicians were surveyed regarding their frequency of use of ocriplasmin and reports of ocular adverse events. RESULTS: There were 270 respondents (11%) who reported treating 1,056 eyes with ocriplasmin. The reports of adverse events (AE) were as follows: acute decline in visual acuity (16.95%), development of submacular fluid or serous retinal detachment (10.23%), dyschromatopsia (9.09%), progression of vitreomacular traction to macular hole (8.71%), development of retinal detachment (2.65%), development of retinal tear (1.99%), development of afferent pupillary defect (1.80%), electroretinography abnormalities (0.57%), crystalline lens instability (0.38%), and vasculitis (0.28%). CONCLUSION: Although the frequency of some ocular AEs reported in this study are comparable to those reported in the phase 3 registration trials, additional phase 4 safety studies are warranted to better understand the pathophysiology and clinical relevance of ocular AEs of ocriplasmin.

Vitrectomy After ocriplasmin for VitreOmacular adhesion Or Macular hole (VAVOOM) study.

BACKGROUND/AIMS: To describe the results of pars plana vitrectomy (PPV) for persistent symptomatic vitreomacular traction (VMT) with or without macular hole (MH) after intravitreal ocriplasmin injection. METHODS: Multicentre retrospective study of eyes that received intravitreal ocriplasmin between January 2013 and January 2014 for symptomatic VMT with or without MH, and then went on to PPV (ocriplasmin-treated group) for persistent pathology, compared with a control group of patients with symptomatic VMT with or without MH who were offered ocriplasmin injection but proceeded directly to PPV (PPV-only group). Intraoperative characteristics, visual acuity (VA) outcomes and spectral-domain optical coherence tomography images were reviewed for the two groups. Primary outcome measure was VA after PPV. RESULTS: 51 eyes of 51 patients underwent PPV after receiving ocriplasmin, and 22 eyes of 22 patients proceeded directly to PPV. Although VA was significantly better at all time points in the PPV-only compared with the ocriplasmin-treated group, at 3 and 6 months after PPV both groups had similar amount of visual improvement. Both groups had similar rates of pathology resolution; 50/51 (98%) eyes in the ocriplasmin group and 22/22 (100%) eyes in the PPV-only group had release of VMT and/or MH closure after PPV. The two groups had similar PPV-related complication rates. CONCLUSIONS: Eyes with persistent symptomatic VMT and/or MH have similarly high rates of pathology resolution as well as similar VA gains regardless of whether they received ocriplasmin prior to PPV.

Two or more dexamethasone intravitreal implants in treatment-naïve patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a biodegradable, sustained-release implant that releases dexamethasone for up to 6 months. We evaluated the efficacy and safety of DEX implant in the treatment of macular edema secondary to retinal vein occlusion (RVO) in treatment-naïve patients. METHODS: A multicenter, retrospective, open-label chart review study investigated the efficacy and safety of DEX implant treatment in 289 patients with macular edema secondary to branch or central RVO (BRVO, CRVO) who received ≥2 treatments with DEX implant in the study eye. Concomitant adjunctive RVO treatments were permitted. Data collected from the time of the first implant (baseline) to 3-6 months after the last implant included best-corrected visual acuity (BCVA) and central retinal thickness measured with optical coherence tomography. In this subgroup analysis, we evaluated outcomes in patients who had received no previous treatment for RVO complications. RESULTS: Thirty-nine patients were treatment-naïve at the time of their first DEX implant (18 BRVO, 21 CRVO). Before the initial DEX implant, the mean duration of macular edema in treatment-naïve patients was 4.9 months, mean central retinal thickness was 550 µm, and mean Early Treatment Diabetic Retinopathy Study BCVA was 8.5 lines (20/125 Snellen). Treatment-naïve patients received a mean of 2.9 implants, either as monotherapy (n = 12) or with adjunctive RVO treatments (n = 27). The mean interval between implants was 177 days. After the first through sixth implants, mean changes from baseline BCVA ranged from +3.0 - +8.0 lines, and mean decreases from baseline central retinal thickness ranged from 241-459 µm. BCVA improved in both BRVO and CRVO and in both phakic and pseudophakic eyes. Overall, 83.8 % of treatment-naïve patients gained ≥2 lines in BCVA, 70.3 % gained ≥3 lines in BCVA, and 56.4 % achieved central retinal thickness ≤250 µm. The most common adverse event was increased intraocular pressure. Fifteen treatment-naïve patients had intraocular pressure ≥25 mm Hg; none required laser or incisional glaucoma surgery. CONCLUSION: Treatment with 2 or more DEX implants had a favorable safety profile and improved visual acuity and anatomic outcomes when used, either alone or with adjunctive RVO therapy, as initial treatment for RVO-associated macular edema. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 , registered on August 5, 2011.

Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a sustained-release biodegradable implant approved for treatment of macular edema associated with retinal vein occlusion (RVO). The safety and efficacy of treatment of RVO-associated macular edema with sequential DEX implants in clinical practice was evaluated in patients who received DEX implant as monotherapy compared with patients who received DEX implant in combination with other RVO treatments. METHODS: A multicenter, retrospective, open-label chart review study (one study eye/patient) evaluated use of DEX implant and outcomes in 289 patients with branch or central RVO who received at least 2 DEX implant treatments in the study eye. Data were collected from the time of the first implant (baseline) to 3-6 months after the last implant. Subgroup analysis evaluated outcomes in patients receiving only DEX implant during the study versus patients receiving DEX implant plus adjunctive RVO treatments. Endpoints included best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change from baseline. RESULTS: DEX implant was used as monotherapy in 84 (29.1%) patients and in combination with other therapy in 205 (70.9%) patients. Mean number of DEX implant treatments received was 3.1 in the monotherapy group and 3.3 in the combination therapy group (P = 0.344). Mean time between implants was longer in the combination therapy group (177 vs. 151 days, P < 0.001). Mean change from baseline BCVA after the first through sixth DEX implants ranged from +0.6 to +3.4 lines in the monotherapy group and +1.3 to +2.8 lines in the combination therapy group. Mean decrease from baseline CRT ranged from 165 to 230 µm in the monotherapy group and 136 to 175 µm in the combination therapy group. Increased intraocular pressure was more common in the combination therapy group. CONCLUSIONS: Treatment of RVO-associated macular edema with at least 2 sequential DEX implants was safe and effective both when used alone and when combined with other RVO treatments. Improvements in BCVA and CRT were generally similar in the monotherapy and combined therapy groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 .

Frequency and characteristics of intraocular inflammation after aflibercept injection.

PURPOSE: To report the frequency and characteristics of intraocular inflammation after intravitreal aflibercept injection. METHODS: A single-center retrospective study was performed in patients who received intravitreal aflibercept from November 2011 through June 2013. RESULTS: There were 28 cases of intraocular inflammation after a total of 5,905 aflibercept injections among 1,660 patients. The mean baseline acuity was 20/57, which decreased to 20/179 at diagnosis (P < 0.0001) but recovered to 20/59 at Month 1, 20/57 at Month 3, and 20/52 at Month 6 (P = not significant). Vitreous culture and injection of antibiotics were performed in eight cases, and all were culture negative; the remainder received only topical corticosteroids. CONCLUSION: The frequency of inflammation after aflibercept was 0.47% per injection. Visual acuity and inflammation returned to baseline within 1 month in most cases with topical corticosteroid treatment.