Patient-reported prevalence of metamorphopsia and predictors of vision-related quality of life in vitreomacular traction: a prospective, multi-centre study

© 2018, The Author(s). Objectives: To report the prevalence and severity of metamorphopsia, estimate its impact on vision-related quality of life (VRQoL) and evaluate predictors of VRQoL in patients with vitreomacular traction (VMT). Patients and methods: A prospective, cross-sectional multi-centre study in the United Kingdom of 185 patients with VMT, with or without a full thickness macular hole (FTMH). Self-reported metamorphopsia was determined using the metamorphopsia questionnaire. VRQoL was assessed using the Visual Function Questionnaire (VFQ-25). Physicians recorded clinical and ocular characteristics in both eyes including a physician assessment of metamorphopsia. ANOVA and predicted least-squares means were used to estimate the impact of metamorphopsia on VRQoL. Predictors of VRQoL were assessed using ordinary-least-squares regression adjusting for clinically important variables. Results: The prevalence of self-reported metamorphopsia was 69.7% (95% CI 62.6–76.3%) and was higher in eyes with a concomitant FTMH vs. without FTMH (85.4% vs. 64.2%). Physician assessment of metamorphopsia was 53.0% (95% CI: 45.5–60.3%). Comparing eyes with metamorphopsia vs. without metamorphopsia, the VFQ-25 composite score was lower (82.3 vs. 91.4), and mean VA (LogMAR) was worse (0.44 vs. 0.33). The largest difference in VFQ-25 scores was observed for near activities (metamorphopsia: 75.3, No metamorphopsia: 90.2). The adjusted model showed that metamorphopsia severity and age were significantly associated with lower VFQ-25 scores. Conclusion: Metamorphopsia was highly prevalent in patients with VMT and associated with significantly lower VRQoL. Physician assessment of symptoms underestimated the self-reported presence of metamorphopsia. Metamorphopsia severity acts as a predictor of impaired VRQoL, over and above decrements due to reduced vision

Dexamethasone intravitreal implant in the treatment of diabetic macular edema

Pravin U Dugel,1,2 Francesco Bandello,3 Anat Loewenstein4 1Retinal Consultants of Arizona, Phoenix, AZ, 2Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 3Department of Ophthalmology, University Vita-Salute Scientific Institute San Raffaele, Milan, Italy; 4Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Abstract: Diabetic macular edema (DME) resembles a chronic, low-grade inflammatory reaction, and is characterized by blood–retinal barrier (BRB) breakdown and retinal capillary leakage. Corticosteroids are of therapeutic benefit because of their anti-inflammatory, antiangiogenic, and BRB-stabilizing properties. Delivery modes include periocular and intravitreal (via pars plana) injection. To offset the short intravitreal half-life of corticosteroid solutions (~3 hours) and the need for frequent intravitreal injections, sustained-release intravitreal corticosteroid implants have been developed. Dexamethasone intravitreal implant provides retinal drug delivery for ≤6 months and recently has been approved for use in the treatment of DME. Pooled findings (n=1,048) from two large-scale, randomized Phase III trials indicated that dexamethasone intravitreal implant (0.35 mg and 0.7 mg) administered at ≥6-month intervals produced sustained improvements in best-corrected visual acuity (BCVA) and macular edema. Significantly more patients showed a ≥15-letter gain in BCVA at 3 years with dexamethasone intravitreal implant 0.35 mg and 0.7 mg than with sham injection (18.4% and 22.2% vs 12.0%). Anatomical assessments showed rapid and sustained reductions in macular edema and slowing of retinopathy progression. Phase II study findings suggest that dexamethasone intravitreal implant is effective in focal, cystoid, and diffuse DME, in vitrectomized eyes, and in combination with laser therapy. Ocular complications of dexamethasone intravitreal implant in Phase III trials included cataract-related events (66.0% in phakic patients), intraocular pressure elevation ≥25 mmHg (29.7%), conjunctival hemorrhage (23.5%), vitreous hemorrhage (10.0%), macular fibrosis (8.3%), conjunctival hyperemia (7.2%), eye pain (6.1%), vitreous detachment (5.8%), and dry eye (5.8%); injection-related complications (eg, retinal tear/detachment, vitreous loss, endophthalmitis) were infrequent (<2%). Dexamethasone intravitreal implant offers a viable treatment option for DME, especially in cases that are persistent or treatment (anti-vascular endothelial growth factor/laser) refractory. Keywords: corticosteroids, dexamethasone, intravitreal, implant, macular edema, diabetic retinopath

Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2)

J Michael Jumper,1 Pravin U Dugel,2,3 Sanford Chen,4 Kevin J Blinder,5 John G Walt6 On behalf of the ECHO Study Group 1West Coast Retina Medical Group, San Francisco, CA, USA; 2Retinal Consultants of Arizona, Phoenix, AZ, USA; 3USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 4Orange County Retina, Santa Ana, CA, USA; 5The Retina Institute, St Louis, MO, USA; 6Allergan plc, Irvine, CA, USA Purpose: To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) antagonists in the treatment of macular edema secondary to retinal vein occlusion (RVO) in clinical practice.Patients and methods: A multicenter retrospective study of the medical records of 165 patients (95 branch RVO, 70 central RVO) treated with at least three anti-VEGF injections in the study eye was conducted. Available data collected for at least 6 months after the first injection included Snellen best-corrected visual acuity (BCVA), central retinal thickness (CRT) by time-domain optical coherence tomography (TD-OCT) or spectral-domain optical coherence tomography (SD-OCT), anti-VEGF injections, other treatments/procedures for RVO, and adverse events.Results: At baseline prior to anti-VEGF treatment, mean BCVA was 20/80 Snellen equivalent and mean CRT was 499 µm. Mean number of anti-VEGF injections received was 7.1 during the first year, 5.4 during the second year, and 5.9 during the third year; 51.3% (842/1,641) of injections were ranibizumab, 44.1% (724/1,641) were bevacizumab, and 4.6% (75/1,641) were aflibercept. One in five patients received concomitant focal laser treatment. The percentage of patients achieving both BCVA of 20/40 or better and CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT at the same visit (primary endpoint) was 26.1% (30/115) after the first anti-VEGF injection and ranged from 20.0% (7/35) to 36.7% (11/30) after the first 16 injections. After each anti-VEGF injection from the 1st to the 16th, <60% of patients achieved 20/40 or better BCVA and ≤70% of patients achieved CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT. The most common treatment-related adverse event was blurry or cloudy vision.Conclusion: In this real-world study, a mean of five to seven anti-VEGF injections was administered yearly, and the response to anti-VEGF therapy was suboptimal in many patients. Anti-VEGF therapy was well tolerated. Keywords: aflibercept, bevacizumab, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, visual acuity&nbsp

Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema

Szilárd Kiss,1 Hitesh S Chandwani,2 Ashley L Cole,2 Vaishali D Patel,2 Orsolya E Lunacsek,3 Pravin U Dugel4 1Department of Ophthalmology, Weill Cornell Medical College, New York, NY, 2Global Health Economics and Outcomes Research, Allergan, Inc., Irvine, CA, 3Global Health Economics and Outcomes Research, Xcenda, LLC, Palm Harbor, FL, 4Retinal Consultants of Arizona and USC Eye Institute, Phoenix, AZ, USA Purpose: To examine the comorbidity profile and update estimates of health care resource utilization for commercially insured, working-age adults with diabetic macular edema (DME) relative to a matched comparison group of diabetic adults without DME. Additional comparisons were made in the subgroup of pseudophakic patients. Patients and methods: A retrospective matched-cohort study of commercially insured diabetic adults aged 18–63 years was conducted using medical and outpatient pharmacy claims (July 1, 2008–June 30, 2013). Outcomes included diabetes-related and ocular comorbidities and health care resource utilization (any health care visit days, outpatient visit days, inpatient visit days, emergency room visits, eye care-related visit days, unique medications) in the 12-month post-index period. Results: All diabetes-related and ocular comorbidities were significantly more prevalent in DME cases versus non-DME controls (P<0.05). A significantly greater proportion of DME cases utilized eye care-related visits compared with non-DME controls (P<0.001). DME cases had almost twice the mean number of total health care visit days compared to non-DME controls (28.6 vs 16.9 days, P<0.001), with a minority of visit days being eye care-related (mean 5.1 vs 1.5 days, P<0.001). Similar trends were observed in pseudophakic cohorts. Conclusion: This working-age DME population experienced a mean of 29 health care visit days per year. Eye care-related visit days were a minority of the overall visit burden (mean 5 days) emphasizing the trade-offs DME patients face between managing DME and their overall diabetic disease. Insights into the complex comorbidity profile and health care needs of diabetic patients with DME will better inform treatment decisions and help optimize disease management. Keywords: health care resource utilization, diabetes, real-world evidence, pseudophakic, retinal diseas