INCIDENCE OF NEW DIABETIC MACULAR EDEMA IN FELLOW EYES OF PATIENTS IN THE VISTA AND VIVID STUDIES.

PURPOSE: To characterize diabetic macular edema (DME) incidence in fellow eyes of patients treated for DME in the study eye. METHODS: This post hoc analysis of VISTA/VIVID data evaluated fellow eyes without DME at baseline through Week 100. Diabetic macular edema presence in the fellow eye was inferred by investigator-reported DME adverse events and use of DME treatments. RESULTS: Over 100 weeks, 44.9%, 44.2%, and 42.9% of fellow eyes developed DME in the intravitreal aflibercept injection 2 mg every 4 weeks (n = 245), intravitreal aflibercept injection 2 mg every 8 weeks (n = 258), and laser control (n = 252) groups, respectively. Mean time to DME development in combined treatment groups was ∼6 months. Multivariable regression analysis confirmed patients with shorter diabetes duration (hazard ratio per 10-year decrease, 1.16; 95% confidence interval, 1.03-1.30; P = 0.0160) and thicker baseline study eye central subfield thickness (hazard ratio per 10- µ m increase, 1.01; 95% confidence interval, 1.01-1.02; P = 0.0002) were at higher risk of developing DME in the fellow eye. CONCLUSION: Among patients with DME in one eye at baseline, almost half developed DME in the fellow eye over 2 years. Shorter duration of diabetes and thicker study eye central subfield thickness were predictors of DME development in the fellow eye.

OUTCOMES OF PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION TREATED WITH ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY FOR THREE OR MORE YEARS: A Review of Current Outcomes.

PURPOSE: To summarize the findings of long-term outcomes of anti-vascular endothelial growth factor (VEGF) therapy (≥36 months) in patients with exudative age-related macular degeneration. METHODS: Studies reporting long-term outcomes (≥36 months) of anti-VEGF therapy (n = 11) were identified and analyzed for changes in visual acuity (VA), optical coherence tomography, and safety findings. RESULTS: Six prospective extension studies of Phase 3 clinical trials and five retrospective evaluation studies were identified. The largest improvements in VA with anti-VEGF treatment were found in Years 1 to 2 after treatment initiation. In five studies, VA ultimately declined below patients' pretreatment initial baseline; in three studies, VA ultimately returned to patients' baseline; in three studies, VA decreased but ultimately remained improved over patients' baseline. There was a trend demonstrating that a higher frequency of intravitreous injections showed a better maintenance in VA. Rates of adverse events were similar to previous registration studies of anti-VEGF drugs. CONCLUSION: The body of evidence to date regarding long-term anti-VEGF treatment indicates a variable course at greater than 36 months follow-up and seems to be dependent on the treatment protocol. Consistent dosing with fluid-free interval is suggested to maintain VA gains in patients with exudative age-related macular degeneration. There is no evidence suggesting that there are additional adverse events from long-term anti-VEGF use.

Relationship between corneal hysteresis and optic nerve parameters measured with spectral domain optical coherence tomography.

BACKGROUND: Corneal hysteresis (CH) has been associated with visual field damage in glaucoma and is related to the velocity of perimetric glaucoma progression. We undertook this investigation to determine whether CH is associated with structural markers of glaucoma damage on spectral domain optical coherence tomography (SD-OCT). METHODS: In this retrospective study, 131 patients under glaucoma evaluation were evaluated with SD-OCT (Cirrus; Carl Zeiss Meditec, Dublin, CA) and had CH measurements with the ocular response analyzer (Reichert, Inc., Buffalo, NY). Pearson and partial correlation adjusting for age were preformed to examine the association between CH and variables of interest. Generalized estimating equations were used to construct simple and multiple linear models. RESULTS: While Pearson correlations were modest overall, CH best correlated with mean deviation (MD; r = 0.19) followed by average retinal nerve fiber layer (RNFL) thickness (r = 0.18) and vertical cup to disc ratio (r = -0.11) in the open angle glaucoma group. In univariable models, CH varied as a function of MD (ß = 0.1, 95 % CI 0.03, 0.1; p < 0.001) and of average RNFL thickness (ß = 0.2, 95 % CI 0.1, 0.4; p = 0.001). In a multivariable analysis including MD, age, average RNFL thickness, and glaucoma status, MD (p = 0.001) and age (p < 0.001) retained significant associations with CH. CONCLUSIONS: In patients under evaluation and treatment for glaucoma, CH was more closely related to visual field MD than to structural markers of glaucoma damage as measured by SD-OCT.

Ocular benzalkonium chloride exposure: problems and solutions.

Preservatives in multidose formulations of topical ophthalmic medications are crucial for maintaining sterility but can be toxic to the ocular surface. Benzalkonium chloride (BAK)-used in approximately 70% of ophthalmic formulations-is well known to cause cytotoxic damage to conjunctival and corneal epithelial cells, resulting in signs and symptoms of ocular surface disease (OSD) including ocular surface staining, increased tear break-up time, and higher OSD symptom scores. These adverse effects are more problematic with chronic exposure, as in lifetime therapy for glaucoma, but can also manifest after exposure as brief as seven days. Multiple strategies are available to minimize or eliminate BAK exposure, among them alternative preservatives, preservative-free formulations including sustained release drug delivery platforms, and non-pharmacological therapies for common eye diseases and conditions. In this paper, we review the cytotoxic and clinical effects of BAK on the ocular surface and discuss existing and emerging options for ocular disease management that can minimize or eliminate BAK exposure.

Early Real-World Physician Experience with an Intracanalicular Dexamethasone Insert.

Purpose: To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy. Patients and Methods: 23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys' responses to determine the early impressions of the respondents. Results: Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain. Conclusion: The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.

Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a Dexamethasone Intracanalicular Insert in Healthy Adults.

PURPOSE: Intracanalicular dexamethasone insert is a resorbable sustained-release polyethylene glycol-based hydrogel insert delivering a 0.4 mg tapered dose of dexamethasone for up to 30 days to the ocular surface. It is FDA-approved for treating inflammation and pain after ocular surgery. It has also been studied for ocular surface diseases such as allergic conjunctivitis. This study assessed the plasma pharmacokinetic (PK) parameters of dexamethasone following intracanalicular insertion. PATIENTS AND METHODS: Study subjects (N=16) were healthy adults. A dexamethasone insert was unilaterally placed into the canaliculus, and blood samples were obtained for analysis 1 hour prior to insertion and 1, 2, 4, 8, 16, 24 hours and 4, 8, 15, 22 and 29 days after insertion. Safety analyses included slit lamp and dilated fundus examinations, best corrected visual acuity, intraocular pressure (IOP) and adverse events (AEs). RESULTS: Plasma results were below the lower limit of quantitation (LLOQ) at all time points in five subjects (31.3%). Among subjects with quantifiable plasma concentrations, Cmax was <1 ng/mL (range, 0.05 to 0.81 ng/mL), AUC0-last ranged from 0.13 to 7.18 h∙ng/mL, and Tmax ranged from 4.0 to 163.0 hours. Mean (SD) IOP increased from 16.3 (1.4) mmHg at baseline to 19.3 (3.2) at Day 22 but returned to baseline after treatment. No changes occurred in dilated fundus, punctum, or visual acuity examinations. CONCLUSION: The dexamethasone 0.4 mg insert results in minimal systemic exposure following intracanalicular administration.

Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis.

PURPOSE: The purpose of this study was to evaluate the efficacy and safety of a dexamethasone intracanalicular ocular insert for the treatment of allergic conjunctivitis. DESIGN: Multicenter, randomized, double-masked, placebo-controlled, Phase 3 clinical trial. METHODS: Subjects with allergic conjunctivitis were randomized 1:1 to receive a dexamethasone insert or a placebo insert in both eyes and were evaluated using a modified version of the conjunctival allergen challenge (CAC) model. After inserts were placed in office, a series of 4 closely spaced post-insertion CACs were conducted at weeks 1, 2, and 4 across approximately 30 days. Primary efficacy endpoints, assessed at week-1 CAC-day 8, were reported by subjects of ocular itching at 3, 5, and 7 minutes post CAC and investigator-evaluated conjunctival redness at 7, 15, and 20 minutes post CAC. RESULTS: For the primary endpoints, dexamethasone inserts showed statistically significantly lower mean ocular itching scores than placebo at all time points (P <.001), with differences favoring dexamethasone inserts over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively) and statistically significantly lower conjunctival redness scores at 20 minutes (P <.05) but not at 7 or 15 minutes (P ≥.05). Results also showed statistically significantly less itching and conjunctival redness at 31 and 29 of 33 other time points, respectively (P <.05). There were no serious adverse events; 1 subject had elevated intraocular pressure in both eyes. CONCLUSIONS: Data presented in this study demonstrate the potential for a single, physician-administered dexamethasone intracanalicular insert to provide relief of ocular itching for up to 4 weeks in subjects with allergic conjunctivitis, while maintaining a favorable safety profile.

Prevention of Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery: The PROMISE Trial.

BACKGROUND AND OBJECTIVE: To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema (ME) following cataract surgery. PATIENTS AND METHODS: This phase 2, prospective, interventional, single-masked, randomized trial at a single academic center included 30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main outcome measures included treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities as detected by optical coherence tomography at any follow-up visit), a 30% or greater increase from preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters from Day 7 due to retinal thickening. RESULTS: There were similar incidences of AEs between the two groups and no clinically serious ocular AEs in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161). Compared to the study group, the control group had a significantly greater increase in central subfield thickness (CST) at Day 30 (50.05 µm vs. 7.95 µm; P = .040) and Day 60 (56.45 µm vs. 3.02 µm; P = .010). However, the difference in CST between groups was no longer significant at Day 90 (50.31 µm vs. 18.48 µm; P = .12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 8.52; P = .66). CONCLUSIONS: Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant AEs. Although there were significant differences in ME incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of VA. Further larger trials are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:170-178.].

Twenty-Four-Month OCTA Assessment in Diabetic Patients Undergoing Fixed-Interval Intravitreal Aflibercept Therapy.

BACKGROUND AND OBJECTIVE: Evaluate capillary perfusion density (CPD) in patients with diabetic macular edema (DME) undergoing fixed intravit-real aflibercept injections (IAI) through 24 months. PATIENTS AND METHODS: Prospective, interventional, single-arm study enrolling 20 patients with persistent DME. Patients received IAI every 4 weeks until DME resolution followed by extension to every 8 weeks. Optical coherence tomography angiography was obtained at baseline, 6, 12, and 24 months. RESULTS: Sixteen of 20 eyes completed the study. Baseline mean central subfield thickness was 420 µm, which improved to 251 µm (P < .001). The mean best-corrected visual acuity (BCVA) improved by 5.5 letters (P = .042). The whole superficial CPD decreased by 5.3% (P = .001) and the deep CPD decreased by 4.4% (P = .009). Better BCVA correlated with less CPD loss within the superficial parafovea (r = +0.66 [0.23, 0.88]; P = .006) and whole (r = +0.60 [0.12, 0.85]; P = .017) areas. CONCLUSION: Superficial and deep CPD decreased despite fixed IAI through 24 months. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:448-455.].

Diabetic Macular Edema Treated With Intravitreal Aflibercept Injection After Treatment With Other Anti-VEGF Agents (SWAP-TWO Study)-12-Month Analysis.

Purpose: This article reports 12-month outcomes of patients with diabetic macular edema previously treated with other antivascular endothelial growth factor agents and transitioned to fixed dosing of intravitreal aflibercept (IAI). Methods: This prospective, single-arm study enrolled patients to receive IAI 2 mg (0.05 mL) every 4 weeks until optical coherence tomography demonstrated no fluid. Patients then received fixed dosing of IAI 2 mg once every 8 weeks through 12 months. Primary outcome was mean absolute change from baseline central subfield thickness (CST) at 12 months measured by optical coherence tomography. Results: Twenty eyes were enrolled. At baseline, best-corrected visual acuity was 70.0 letters, mean CST was 419.7 µm ± 92.0, superficial capillary perfusion density (CPD) was 46.0 ± 4.2%, and deep CPD was 50.8 ± 4.3%. At 12 months, the mean CST improved to 287.2 µm ± 80.2 (P < .001), superficial CPD decreased to 43.6 ± 4.8% (P = .04), and deep CPD decreased to 47.6 ± 4.8% (P = .05). Conclusions: Patients who switched to fixed dosing of IAI demonstrated significant anatomic improvements in CST at 12 months. CPD values decreased significantly both in superficial and deep layers without significant changes in vision.

Diabetic macular edema treated with intravitreal aflibercept injection after treatment with other anti-VEGF agents (SWAP-TWO study): 6-month interim analysis.

BACKGROUND: Diabetic macular edema (DME) is an important cause of vision loss and despite the anatomical and functional improvement achieved with treatment, there are reports of persistent DME regardless of continuous anti-VEGF therapy. The purpose of this study is to examine the effect of patients with DME previously treated with other anti-VEGF agents who are transitioned to intravitreal aflibercept (IAI) on a fixed dosing regimen. METHODS: This prospective study included 20 patients presenting with DME with a history of previous anti-VEGF treatment with ranibizumab or bevacizumab. Patients received a 2 mg (0.05 mL) IAI every 4 weeks until no evidence of fluid by optical coherence tomography (OCT) followed by a fixed dosing schedule of 2 mg IAI once every 8 weeks through 24 months. There was a pre-planned interim analysis of the mean absolute change from baseline central foveal thickness at month 6 as measured by OCT. Secondary outcomes included mean change from baseline in ETDRS visual acuity and anatomic parameters. Optical Coherence tomography angiography (OCTA) capillary perfusion density (CPD) after transitioning to IAI therapy were also reported. RESULTS: Average central subfield thickness on OCT at baseline was 419.7 ± 92.0 and improved to 303.8 ± 73.1 at 6-months (p < 0.001). At 6 months after IAI treatment, BCVA increased + 1.5 letters from baseline (p = 0.38). OCTA CPD analysis revealed significant increase from baseline in the foveal avascular zone in non-proliferative diabetic retinopathy group (p = 0.02). CONCLUSIONS: Patients with prior anti-VEGF therapy who were transitioned to IAI therapy revealed significant anatomic improvements through 6 months.Trial registration Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab (SwapTwo), Trial registration number: NCT02559180. Date of registration: September 24, 2015.https://clinicaltrials.gov/ct2/show/NCT02559180.

Difference in Treatment Effect Between Intravitreal Aflibercept Injection and Laser by Baseline Factors in Diabetic Macular Edema.

BACKGROUND AND OBJECTIVE: To evaluate the effect of baseline factors on differences in vision gains with intravitreal aflibercept injection (IAI) versus laser control in patients with diabetic macular edema (DME). PATIENTS AND METHODS: This was an integrated post-hoc subanalysis of two phase 3 trials (VISTA, VIVID) in patients with DME. Least square (LS) mean differences of patients treated with IAI compared to laser control in best-corrected visual acuity (BCVA) change from baseline at week 100 were evaluated for association with baseline demographics and baseline systemic disease characteristics. RESULTS: At week 100, LS mean differences in BCVA change from baseline with IAI compared to laser control were not significant for association with baseline age, gender, and race or status of glycosylated hemoglobin, body mass index, renal impairment, hypertension, cerebrovascular disease, and ischemic heart disease. CONCLUSION: Vision gains with IAI were significantly greater than laser control and were not influenced by demographics and systemic disease control at baseline. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:167-173.].

Association of Disorganization of Retinal Inner Layers With Visual Acuity Response to Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Secondary to Retinal Vein Occlusion.

Importance: Disorganization of retinal inner layers (DRIL) has demonstrated significant correlations with visual acuity (VA) in center-involved diabetic macular edema. In patients with retinal vein occlusion (RVO) and secondary macular edema, DRIL may be a useful biomarker in determining VA outcomes. Objective: To examine whether DRIL at baseline and after treatment is associated with VA in RVO. Design, Setting, and Participants: A retrospective review of records of 147 patients 18 years or older with treatment-naive branch RVO (BRVO), central RVO (CRVO), or hemispheric RVO (HRVO), with a minimum of 12 months of follow-up, who presented to a tertiary ophthalmic center from December 1, 2010, to January 1, 2016, was conducted. Data collection continued through January 2017. Exclusion criteria included active confounding retinal or ocular disease, history of pars plana vitrectomy, or prior intravitreal injections. Two masked graders calculated a DRIL score based on DRIL presence in 3 predefined regions on spectral-domain optical coherence tomography at baseline, 6 months, and 12 months. A third masked grader was used for discrepancies. Exposures: Anti-vascular endothelial growth factor (AVF) therapy (ranibizumab, aflibercept, or bevacizumab) determined by the treating physician. Main Outcomes and Measures: The DRIL score at baseline for determining VA outcomes and correlation of VA with changes in DRIL burden in response to AVF therapy. Results: In the 147 patients (mean [SD] age, 68.9 [13.1] years; 75 [51.0%] female), baseline DRIL was seen in 91 eyes (61.9%). In the BRVO group but not the CRVO group, baseline DRIL was associated with lower baseline Early Treatment Diabetic Retinopathy Study (ETDRS) score (score of 66.7 for no DRIL vs 54.6 for DRIL, P = .002). Absence of DRIL at baseline in the CRVO/HRVO group correlated with greater VA gains at 6 months, adjusting for baseline VA (score change of 19.50 for no DRIL vs 12.72 for DRIL; P = .04). During 12 months, continued DRIL presence in BRVO was associated with less VA gain up to 6 months (score change of 6.2 for the DRIL increase group vs 18.6 for the DRIL decrease group vs 2.9 for the DRIL stable group; P = .02). Increasing DRIL scores in CRVO/HRVO were associated with reduced VA improvement at 6 months (score change of -0.12 for the DRIL increase group vs 16.90 for the DRIL decrease group vs 8.45 for the DRIL stable group; P = .002) and 12 months (score change of -1.91 for the DRIL increase group vs 17.83 for the DRIL decrease group vs 6.97 for the DRIL stable group; P < .001). Conclusions and Relevance: Baseline DRIL presence and DRIL burden changes with AVF therapy for macular edema secondary to RVO may be useful biomarkers of ETDRS score improvements.

Baseline Ocular Characteristics of Patients Undergoing Initiation of Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema.

BACKGROUND AND OBJECTIVES: Patients with diabetic macular edema (DME) have variable anatomic and visual responses to anti-vascular endothelial growth (VEGF) treatments based on their presenting visual acuity (VA). The aim of study is to report the baseline ocular and imaging characteristics of patients presenting with DME who were treatment-naïve and who initiated anti-VEGF in routine clinical practice. PATIENTS AND METHODS: Single-center, cross-sectional study of 638 patients. Subjects were divided into two VA groups: Early Treatment Diabetic Retinopathy Study (ETDRS) less than 70 and ETDRS greater than 70 and ocular variables were compared between groups. RESULTS: Average central subfield thickness (CST) was 363.5 µm, cube volume was 11.7 mm3, and cube average thickness (CAT) was 326.1 µm. Additionally, 21.5% had subretinal fluid (SRF), and 50.5% had hard exudates on presentation. Eyes with ETDRS less than 70 had greater CAT (338.5 µm3 vs. 313.2 µm3; P < .001), greater cube volume (12.2 mm3 vs. 11.3 mm3; P < .001), greater CST (383.5 µm vs. 350.0 µm; P < .001), and SRF (25.5% vs. 17.3%; P = .012). Furthermore, 7.64% had glaucoma, 1.3% had dry age-related macular degeneration, 4.5% of patients were vitrectomized, and 28.7% were pseudophakic. Regarding diabetic stage, 37% had proliferative diabetic retinopathy (PDR) and 63% presented with nonproliferative diabetic retinopathy. Patients presenting with ETDRS less than 70 were more likely to have a history of vitrectomy (7.1% vs. 1.9%, P = .002) and presence of PDR (42.3% vs. 31.4%, P = .004). CONCLUSION: The results describe a population of patients from a routine clinical practice not entirely represented in clinical trials, with key differences in ocular characteristics seen between VA groups. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:69-75.].

Characterization of Patients With Geographic Atrophy in Routine Clinical Practice.

BACKGROUND AND OBJECTIVE: Geographic atrophy (GA) affects millions of patients with age-related macular degeneration (AMD) worldwide, leading to significant, irreversible visual impairment. This study aims to characterize the visual impairment of patients with GA in a routine clinical practice. PATIENTS AND METHODS: This single-center, cross-sectional study used a novel natural language processing to select 1,045 GA cases utilizing the macula examination records from 19,359 patients with AMD. RESULTS: Patients were classified based on the diagnosis of the fellow-eye as follow: 502 in group 1 (GA:GA), 403 in group 2 (GA : choroidal neovascularization), and 234 in group 3 (GA : early / intermediate AMD). Best-corrected visual acuity (BCVA) in the affected eye was 50.3 (± 22.1) letters in group 1, 52.5 (± 21.3) letters in group 2, and 48.5 (± 23.6) letters in group 3 (P < .05). Visual impairment (ineligibility for an unrestricted driver license) was present in 70.5% of group 1, 59.7% of group 2, and 39.6% of group 3. Legal blindness (BCVA < 20 letters in the best-seeing eye) was seen in 2.2% of group 1, 3% of group 2, and 0.8% of group 3. CONCLUSION: Differences in visual impairment between subgroups of patients with GA can be seen in routine clinical practice. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:93-98.].

Characterization of the Systemic Findings of Patients Undergoing Initiation of Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Routine Clinical Practice.

BACKGROUND AND OBJECTIVES: Previous studies have validated that baseline visual acuity (VA) can predict a variance response to anti-vascular endothelial growth factor (VEGF) treatment. However, little is known about the initial systemic presentation of diabetic macular edema (DME) in clinical practice. The aim of this study is to report the baseline systemic findings of patients presenting with DME who received anti-VEGF in clinical practice. PATIENTS AND METHODS: A retrospective chart review of patients with DME presenting between April 2012 and December 2016 was performed. RESULTS: Data from 638 patients were retrieved. The average patient age was 63.1 years (±11.6 years), and 53% were male. There were 95.6% type II diabetics with an average HgA1c of 8.1% (range: 5.1% to 14.5%). Insulin use was present in 67%, biguanides in 43%, sulfonylureas in 32.8%, DDP4 inhibitors in 11.8%, thiazolidinediones in 3.9%, and D-phenylalanine derivatives in 0.94%. Hypertension was present in 78.4% of patients, cardiac comorbidities in 29.3%, peripheral vascular disease in 16.5%, and renal insufficiency in 22.6%. Patients were then split into two different cohorts based on VA (ETDRS < 70 and ETDRS ≥ 70), and variables were compared between groups. CONCLUSION: It was shown that older age, hypertension, elevated creatinine, elevated high-density lipoprotein cholesterol, and decreased biguanide use were positively associated with worse presenting VA. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:16-24.].

Outer Retinal Tubulation and Neovascular Age-Related Macular Degeneration: A Review of the Pathogenesis and Clinical Implications.

Outer retinal tubulation (ORT) is a retinal finding that can mimic intraretinal fluid and has been identified with spectral-domain optical coherence tomography in patients with age-related macular degeneration (AMD). The purpose of this review is to summarize the findings related to the pathogenesis of ORT and its clinical implications. Studies reporting the pathogenesis and the clinical implications of ORT in patients with AMD were identified and summarized. A total of 18 studies were included in this review. The body of evidence to date regarding ORT in patients with AMD indicates that ORT is a structure associated with advanced macular diseases that does not require anti-vascular endothelial growth factor treatment. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:870-876.].

Switching Anti-Vascular Endothelial Growth Factors in Refractory Neovascular Age-Related Macular Degeneration.

BACKGROUND AND OBJECTIVE: Anti-vascular endothelial growth factor (VEGF) therapy is the treatment of choice for cases with neovascular age-related macular degeneration (AMD). Switching to an alternate anti-VEGF has been suggested as a possible option for resistant cases. The purpose of this review is to evaluate whether the timing of switching affects treatment outcomes. PATIENTS AND METHODS: A review of published literature was performed looking at all studies where patients with refractory neovascular AMD were switched to an alternative anti-VEGF. Studies were then stratified based on the timing of switching into early (< 12 previous injections) and late (> 12 previous injections). RESULTS: A total of 38 studies were identified: 18 where patients were switched early and 20 where they were switched late. Both subgroups showed anatomic improvement after switching, with limited visual gains. CONCLUSION: There are insufficient data to recommend early versus late switching. However, both groups showed a reduction of fluid on optical coherence tomography and visual gains in 25% to 30% of patients. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:166-170.].

36-Month Evaluation of Intravitreous Aflibercept Injection for Wet Age-Related Macular Degeneration in Patients Previously Treated With Ranibizumab or Bevacizumab.

BACKGROUND AND OBJECTIVE: In the ASSESS study, patients with neovascular age-related macular degeneration transitioned from other anti-vascular endothelial growth factor therapies to intravitreous aflibercept (Eylea; Regeneron, Tarrytown, NY) injections (IAI). The purpose was to determine the 36-month outcomes following the change from a fixed 24-month IAI dosing regimen to a routine clinical practice regimen. PATIENTS AND METHODS: Patients were treated with a fixed bimonthly regimen for the first 2 years. In the third year, patients were managed according to routine clinical practice. RESULTS: A total of 18 patients completed the 36 months and were considered for statistical analyses. At 36 months, a nonsignificant decrease of -37.8 µm in central subfield thickness and a nonsignificant gain of 5.8 letters from baseline were observed. CONCLUSION: Despite the significant visual and anatomical gains observed in the 2 years of fixed-dosing IAI, there was gradual decline in these improvements when patients were transitioned to a variable regimen. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:179-185.].