Management and Outcomes for Neovascular Age-Related Macular Degeneration: Analysis of United States Electronic Health Records.

PURPOSE: To assess anti-vascular endothelial growth factor (VEGF) management patterns and anatomic and visual acuity (VA) outcomes among patients with neovascular age-related macular degeneration (nAMD) in United States clinical practice. DESIGN: Retrospective observational cohort study. PARTICIPANTS: Patients (N = 30 106) initiating intravitreal anti-VEGF treatment for nAMD between October 2009 and November 2016. METHODS: Analysis of longitudinal electronic health records from USRetina. MAIN OUTCOME MEASURES: Number of intravitreal injections, OCT examinations, and fluorescein angiography (FA) examinations per study eye during the first 12 months; corrected VA and central retinal thickness (CRT) at 12 months; and number of ophthalmologist visits, stratified by index anti-VEGF agent. RESULTS: Over the first 12 months, patients made a mean of 8.1 (range, 1-39) ophthalmologist visits, received a mean of 6.0 (range, 1-27) anti-VEGF injections, and underwent 7.2 OCT and 5.3 FA examinations per study eye. For eyes with paired baseline and 12-month readings, mean CRT declined from 320 to 271 µm (mean change, -48 µm), and mean VA increased from 60.3 to 61.0 approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letters (mean change, +0.6 letters). Twelve months after initiating index treatment with bevacizumab, ranibizumab, and aflibercept, 19.3%, 15.8%, and 15.5% of eyes, respectively, showed greater than 10-letter gain, whereas 13.2%, 14.7%, and 14.4% of eyes, respectively, showed greater than 10-letter loss. Mean change from baseline VA at 12 months increased linearly with cumulative anti-VEGF injection count: +1.79 versus -0.95 approximate ETDRS letters for eyes receiving 7 or more injections versus fewer than 7 injections. Similarly, the magnitude of the reduction from baseline CRT at 12 months tended to increase linearly with increasing number of anti-VEGF injections. Multivariate linear regression analysis, adjusted for covariates, indicated a significant association between cumulative number of anti-VEGF injections and change from baseline in VA at 12 months, with each unit increase producing an estimated gain of 0.37 approximate ETDRS letters. CONCLUSIONS: This analysis of combined morphologic and functional outcomes of anti-VEGF therapy, the largest conducted to date in nAMD, identified relatively low anti-VEGF injection frequencies, coupled with moderate anatomic and limited VA improvements, in United States clinical practice.

Surgical management of rhegmatogenous retinal detachment: a meta-analysis of randomized controlled trials.

PURPOSE: To examine possible differences in clinical outcomes between pars plana vitrectomy (PPV) and scleral buckling (SB) for uncomplicated rhegmatogenous retinal detachment (RRD). DESIGN: Meta-analysis. PARTICIPANTS: Adult patients with uncomplicated RRD from previously reported randomized controlled trials of PPV and SB. METHODS: A comprehensive literature search using the Cochrane Collaboration methodology to identify randomized controlled trials comparing PPV with SB for uncomplicated RRD. MAIN OUTCOME MEASURES: Analysis was divided into phakic and pseudophakic/aphakic patients. Primary outcome parameters included proportion of primary reattachment and difference of means of best-corrected visual acuity (BCVA) at 6 months or more between the PPV and SB groups. Secondary outcome parameters included the proportion of secondary reattachment and complications between the PPV and SB groups. RESULTS: Seven studies were identified and analyzed for comparing PPV (636 eyes) with SB (670 eyes) for uncomplicated RRD. In the phakic group, there were no significant differences in the proportion of primary reattachments (odds ratio [OR], 1.00; 95% confidence interval [CI], 0.69-1.46) or secondary reattachments (OR, 0.99; 95% CI, 0.34-2.87) between the PPV and SB groups. Meta-analysis showed a statistically significant difference in the logarithm of the minimum angle of resolution (logMAR) BCVA at 6 months between the PPV-treated and SB-treated phakic eyes (mean deviation, 0.14; 95% CI, 0.06-0.21; P<0.0004). In the pseudophakic/aphakic group, there were no significant differences in the proportion of primary reattachments (OR, 1.46; 95% CI, 0.79-2.71) or logMAR BCVA at 6 months between the PPV and SB groups (mean deviation, -0.03; 95% CI, -0.10 to 0.04). A statistically significant difference was noted in the proportion of secondary reattachments (OR, 2.08; 95% CI, 1.08-4.03; P = 0.03) between the PPV and SB groups in pseudophakic/aphakic eyes. Meta-analysis showed a statistically significant rate of cataract progression in the PPV group (OR, 4.11; 95% CI, 2.70-6.25; P<0.00001). CONCLUSIONS: There were no significant differences in the proportions of primary reattachment in the PPV and SB groups in phakic eyes. The SB-treated phakic eyes had better postoperative BCVA at 6 months or more. This is most likely related to higher rates of cataract progression in PPV-treated phakic eyes. There were no significant differences in proportions of primary reattachment and postoperative BCVA at 6 months or more in pseudophakic/aphakic eyes.

Validity of self-report in type 1 diabetic subjects for laser treatment of retinopathy.

PURPOSE: This study sought to determine the validity of self-report of prior panretinal photocoagulation (PRP) and focal photocoagulation (FP) compared with fundus photography. DESIGN: Prospective cohort study. PARTICIPANTS: One thousand three hundred sixty-three type 1 diabetic subjects from the Epidemiology of Diabetes Interventions and Complications (EDIC) study, a subset of the 1441 subjects originally enrolled in the multicenter Diabetes Control and Complications Trial. METHODS: At each annual visit, subjects were asked by EDIC staff whether they had undergone PRP, FP, or both since the last completed annual clinic visit. Fundus photographs were collected from one quarter of the cohort each year and from the entire cohort at EDIC years 4 and 10. Photographs were graded for the presence and extent of PRP and FP. Seventeen years of subject reporting and photograph grading of PRP and FP were compared in EDIC subjects. MAIN OUTCOME MEASURES: The κ, sensitivity, specificity, and positive and negative predictive values were calculated for subject-reported PRP and FP. Factors influencing subject misreporting were investigated. RESULTS: For subject reporting, 1244 (96%) of 1296 subjects with gradable photographs accurately reported whether they had a history of PRP in one or both eyes, and 1259 (97.5%) of 1291 with valid photographs correctly reported their history of FP. For PRP and FP, sensitivities were 90.4% and 74.0%, respectively; specificities were 96.0% and 98.8%, respectively; positive predictive values were 75.9% and 80.3%, respectively; negative predictive values were 98.9% and 98.4%, respectively; and κ values were 0.80 and 0.76, respectively. Risk factors associated with misreporting included prior laser for diabetic retinopathy and prior ocular surgery (each P<0.04). CONCLUSIONS: For subjects with type 1 diabetes, in the absence of a clinical examination or fundus photographs, subject self-report could be a reliable tool in a well-monitored study for assessing laser treatment type in diabetic retinopathy.

Disease burden of neovascular age-related macular degeneration and diabetic macular edema.

Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) are the leading causes of vision impairment in elderly patients and people living with diabetes, respectively. Common features of nAMD and DME include increased vascular permeability, inflammation, and neovascularization. Intravitreal administration of vascular endothelial growth factor (VEGF) inhibitors has been the gold standard for treating retinal diseases, and numerous studies have demonstrated their ability to stabilize disease progression and improve visual acuity. However, many patients struggle with the burden of frequent injections, experience a suboptimal treatment response, or lose vision over time. For these reasons, the outcomes of anti-VEGF treatment are often worse in the real-world compared with clinical trials.

Treatment approaches for neovascular age-related macular degeneration and diabetic macular edema.

Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) can cause substantial disease burden for patients. Several organizations have published clinical guidelines on appropriate diagnosis and treatment recommendations to alleviate this burden. Treatment approaches include both nonpharmacologic methods and pharmacologic therapies, with anti-vascular endothelial growth factor (VEGF) therapy being the standard of care. Anti-VEGF therapy is an effective treatment option for both nAMD and DME; however, long-term patient compliance may be reduced due to the burden of costs, monthly intravitreal injections, and repeat clinic visits to assess clinical response parameters. Emerging treatments and dosing strategies aim to decrease treatment burden and increase patient safety. Retina specialists can play a key role in improving the management of both nAMD and DME by incorporating patient-specific treatment strategies tailored to improve clinical outcomes. Enhanced knowledge of retinal disease therapies will allow clinicians to optimize evidence-based treatment strategies to improve clinical outcomes for their patients.

Small-gauge vitrectomy does not protect against nuclear sclerotic cataract.

PURPOSE: To determine whether the gauge of vitrectomy instrumentation is associated with the progression of nuclear sclerotic cataract. METHODS: A prospective interventional and observational study of patients undergoing vitrectomy surgery for various retinal conditions. Patients had Scheimpflug lens photography in the operated and fellow eye at baseline and at 6 months and 12 months after vitrectomy surgery. RESULTS: Of 42 eyes included in the analysis, 11 had 20-gauge surgery, 22 had 23-gauge surgery, and 9 had 25-gauge surgery. In all operated eyes, vitrectomy surgery led to the significant progression of nuclear sclerotic cataract, compared with the fellow, unoperated eye. This small study was unable to detect a difference in nuclear sclerotic progression when comparing small-gauge surgery (23 and 25 gauge) with standard 20-gauge surgery. CONCLUSION: Removal of the vitreous gel using any-gauge vitrectomy surgery leads to significant progression of nuclear sclerotic cataract at 6 months and 12 months. The findings are consistent with the hypothesis that the vitreous gel is important in protecting the lens from increased exposure to oxygen that leads to the formation of nuclear sclerotic cataract. This increased exposure to oxygen occurs as a result of removing the vitreous gel and is independent of the gauge of vitrectomy instrumentation.

Techniques, rationale, and outcomes of internal limiting membrane peeling.

BACKGROUND: The internal limiting membrane represents the structural interface between the retina and the vitreous and has been postulated to serve several essential functions. Recently, internal limiting membrane peeling has been used in the treatment of a variety of retinal disorders. We review the history, techniques, rationale, and outcomes of internal limiting membrane peeling. METHODS: A review of the literature. RESULTS: Internal limiting membrane peeling has been used to successfully treat a variety of retinal disorders including macular hole, epiretinal membrane, diabetic macular edema, retinal vein occlusion, and others. CONCLUSION: Internal limiting membrane peeling may serve as an important component in the armamentarium of retinal surgery.

Ophthalmic manifestations of rheumatologic disease: diagnosis and management.

Rheumatologic diseases are often associated with ophthalmic findings. Familiarity with and recognition of these ophthalmic presentations are important in the management of both the systemic and ocular manifestations of the disease. Identification of ocular signs and symptoms of rheumatologic disease will allow a more comprehensive approach to treatment of patients with rheumatic conditions.

Cost impact of different treatment regimens of brolucizumab in neovascular age-related macular degeneration: A budget impact analysis.

BACKGROUND: Brolucizumab is a new anti-vascular endothelial growth factor (anti-VEGF) approved for treating neovascular age-related macular degeneration (nAMD). Multiple treatment regimens are available for treating nAMD. These regimens include manufacturer-recommended regimens, pro re nata (PRN) regimens, and treat-and-extend (T&E) regimens, which are based on clinical practice guidelines and data observed in the real-world clinical setting, classified as real-world evidence (RWE). Most budget impact models predict the financial consequences of adding a new drug to the formulary based on the manufacturer-recommended regimen. With different anti-VEGF treatment regimens being used in nAMD by ophthalmologists, it is OBJECTIVE: To estimate the budget impact of different treatment regimens of brolucizumab in nAMD from a US payer perspective. METHODS: A Microsoft Excel-based budget impact model was developed for different treatment regimens of brolucizumab over a 1-year time frame from a US payer perspective. A separate analysis was performed to estimate the budget impact from a US patient population perspective. Model inputs included drug costs, administration costs, physician visit costs, and disease monitoring costs. Outcomes in the budget impact model included the cost per member per month, annual health plan cost, and the US patient population-based annual cost. Based on the prevalence of nAMD in public and commercial health plans, a scenario analysis was conducted on the US population to account for the differences in the drug cost to the public and commercial payers. Further, 1-way sensitivity analyses were conducted to test model assumptions and uncertainty in model inputs. RESULTS: The addition of brolucizumab to the formulary increased the net budgetary impact under PRN and T&E regimens. The maximum increase in expenditure for a hypothetical health plan with 1 million enrollees was associated with the PRN regimen ($824,696), followed by the T&E regimen ($163,101). In contrast, using the manufacturer-recommended and RWE regimens led to an annual saving of $93,068 and $94,170 for the health plan, respectively. In the US patient population model, the introduction of brolucizumab resulted in savings in the manufacturer-recommended ($30.99 million) and RWE regimens ($31.35 million) but led to an increase in annual expenditures for the PRN ($274.58 million) and T&E ($54.30 million) regimens. CONCLUSIONS: Payers need to evaluate the cost impact of different treatment regimens of existing and new anti-VEGFs when making formulary decisions in nAMD management. DISCLOSURES: Mr Siddiqui, Ms Dhumal, Dr Patel, and Dr LeMasters have nothing to disclose. Dr Kamal has received research funding from Cerevel Therapeutics, served as a consultant to Pfizer/Cytel Inc, and received honoraria from Pharmacy Times Continuing Education. Dr Almony has served as a consultant to Cardinal Health and received honoraria from Pharmacy Times Continuing Education and Prime Education.

Clinical and economic burden of neovascular age-related macular degeneration by disease status: a US claims-based analysis.

BACKGROUND: New treatment alternatives have revolutionized the management of nAMD. However, there is limited evidence on the clinical and economic burden of nAMD in commercially insured US patients. OBJECTIVES: To examine the clinical and economic burden in patients with nAMD by disease status in the commercially insured US patient population and to identify drivers of nAMD-related costs. METHODS: Patients with at least 1 International Classification of Diseases, 10th Revision Clinical Modification (ICD-10-CM) diagnosis for nAMD were identified from the IQVIA PharMetrics Plus database between April 2016 and August 2017 (index period). Patients had continuous enrollment for at least 6 months before and at least 12 months after the index date. Eye-level disease status was reported, along with intravitreal anti-VEGF treatment patterns. Health care resource utilization (HRU) (all-cause and nAMD-related) and direct health care costs were estimated over the 12 month follow-up period. Outcomes associated with falls and fractures were also assessed. Multivariate analysis identified drivers of annual nAMD-related outpatient costs among patients with anti-VEGF therapy. Incident patients (defined as those without an nAMD diagnosis 6 months prior to the index date) with at least 18 months of continuous enrollment after the index date were identified for a subset analysis to evaluate documented changes in disease status. RESULTS: A total of 6,076 patients with nAMD were identified for the prevalent cohort; 60.1%, 17.2%, and 5.9% had active CNV, inactive CNV, and inactive scar disease stage at index, respectively. The nAMD-related outpatient visit costs were roughly 4 and roughly 7 times higher, respectively, for the active CNV group ($8,658 [SD = $11,612]) compared with the inactive CNV ($2,406 [SD = $5,510]) and inactive scar ($1,198 [SD = $3,035]) groups (P < 0.0001). About 10% of prevalent patients had a fall/fracture claim over 12 months of follow-up. A total of 3,623 prevalent patients (59.6%) were eligible for the anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 7.7 [4.5] months; mean [SD] number of injections = 6.0 [3.7]). Qualified incident cases comprised 17.8% (n = 1,081) of the prevalent cohort. Approximately 20% of incident eyes with active CNV at baseline transitioned to inactive CNV. A total of 427 incident patients (39.5%) qualified for anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 6.2 [4.7] months, mean [SD] number of injections = 5.2 [3.5]). Significant drivers of total nAMD-related costs were the initial anti-VEGF agent and anti-VEGF injection frequency (P < 0.0001) in both prevalent and incident cohorts. CONCLUSIONS: The clinical and economic burden of nAMD treatment is substantial to the US healthcare system, where economic burden is higher among those with active CNV. Appropriate treatment may increase the duration of inactive disease periods and preserve visual acuity while lowering costs. DISCLOSURES: This study was funded by Allergan, an AbbVie Company. Allergan employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit for publication. Keyloun and Campbell are employees of Allergan. Multani, McGuiness, and Chen are employees of IQVIA, which received funding from Allergan for conducting the analysis. Almony and Shah-Manek have nothing to disclose.

Long-term follow-up of surgical removal of extensive peripapillary choroidal neovascularization in presumed ocular histoplasmosis syndrome.

PURPOSE: To report the long-term visual outcomes of surgical removal of extensive peripapillary choroidal neovascularization associated with presumed ocular histoplasmosis syndrome (POHS). DESIGN: Long-term retrospective review. Follow-up ranged from 14 to 139 months (mean, 68). PARTICIPANTS: Forty consecutive eyes (in 35 patients) undergoing surgical removal of extensive peripapillary choroidal neovascularization associated with POHS at the Barnes Retina Institute between May 1992 and December 2003 were included in this review. Patient age ranged from 5 to 73 years (median, 34.5). All eyes were ineligible for laser treatment by Macular Photocoagulation Study criteria. INTERVENTION: Pars plana vitrectomy and surgical removal of choroidal neovascularization were performed. MAIN OUTCOME MEASURES: Determination of Snellen best-corrected visual acuity (BCVA), funduscopic examination, and intravenous fluorescein angiography were done before surgery and at regular intervals after surgery. RESULTS: In the 23 eyes with subfoveal extension of peripapillary choroidal neovascularization, preoperative BCVA ranged from 20/25 to counting fingers (CF) at 2 feet (median, 20/200). Final postoperative BCVA ranged from 20/15 to CF at 2 feet (median, 20/50). Of 23 eyes, 18 achieved stable or improved BCVA from the preoperative to the final postoperative examination; only 5 eyes had > or =2 lines of decreased BCVA. Overall, 11 of 23 eyes achieved > or =20/40 BCVA at the final postoperative examination. In the 17 eyes in which choroidal neovascularization remained extrafoveal, preoperative BCVA ranged from 20/20 to 20/400 (median, 20/60). Final BCVA ranged from 20/20 to 20/200 (median, 20/20). Of 17 eyes, 15 achieved stable or improved BCVA from preoperative to final postoperative examination; only 2 eyes had > or =2 lines of decreased BCVA. Overall, 14 of 17 eyes achieved > or =20/40 BCVA at the final postoperative examination. CONCLUSIONS: The data from this small retrospective study suggest that surgical removal may provide visual benefit in selected cases of extensive peripapillary choroidal neovascularization associated with POHS. Surgical removal of extensive peripapillary choroidal neovascularization does appear preferable to photoablation. Given the likelihood of multiple treatments with photodynamic therapy or anti-vascular endothelial growth factor therapies, surgical removal provides a potentially efficacious treatment with low recurrence rates and good visual results.

Tilting of radioactive plaques after initial accurate placement for treatment of uveal melanoma.

OBJECTIVE: To evaluate plaque movement as a potential factor in local failure using intraoperative ultrasonography at plaque insertion and removal. METHODS: Prospective study of 162 patients with uveal melanoma undergoing intraoperative B-scan ultrasonography at insertion and removal of iodine 125 plaques. RESULTS: Tilting of the posterior plaque edge more than 1.0 mm away from the sclera was detected in 15 patients (9%) at plaque insertion and in 85 patients (53%) at plaque removal (P < .001). Factors associated with tilt at plaque removal included male sex (P = .009), decreased tumor distance to the fovea and optic disc (P < .001 for both), notched plaque (P = .001), and episcleral hematoma (P = .009). Plaque tilt caused a reduction greater than 10% in actual radiation dose to the tumor apex in 37 patients (23%). Local failure occurred in only 3 patients (2%), all of whom had tilt of 1.95 mm or greater at plaque removal. CONCLUSIONS: Plaque tilt after initial accurate placement occurs frequently during brachytherapy for uveal melanomas and may represent an important cause of local treatment failure. Recognizing and counteracting the effects of plaque tilt may reduce the risk of local failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00459849.

Macular hole closure with triamcinolone-assisted internal limiting membrane peeling.

PURPOSE: To evaluate the anatomic and visual outcomes of patients treated with triamcinolone-assisted internal membrane peeling for macular hole. METHODS: A retrospective chart review of 37 consecutive cases done by a single vitreoretinal surgeon for idiopathic macular hole. All surgery involved triamcinolone-assisted internal limiting membrane peeling. All patients had at least 3-month follow-up. Main outcome measures included anatomic macular hole closure, visual acuity, and operative complications. RESULTS: Mean follow-up was 11 months (range, 3-56 months). Anatomic macular hole closure was achieved in 36 eyes (97%). Mean overall preoperative visual acuity was 20/150 and final acuity was 20/63 (P < 0.0001). Nineteen eyes (51%) had best corrected visual acuity at most recent postoperative visit of > or =20/50. There were no postoperative complications. CONCLUSIONS: Triamcinolone-assisted internal limiting membrane peel is an effective surgical technique in macular hole surgery. Use of triamcinolone acetonide did not adversely impact macular hole closure. Anatomic closure rates and visual outcomes compared favorably with published literature on macular hole surgery.

Vision Outcomes Following Anti-Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice.

PURPOSE: To determine monitoring and treatment patterns and vision outcomes in real-world patients initiating anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME). DESIGN: Retrospective interventional cohort study. METHODS: Setting: Electronic medical record analysis of Geisinger Health System data. STUDY POPULATION: A total of 110 patients (121 study eyes) initiating intravitreal ranibizumab or bevacizumab for DME during January 2007‒May 2012, with baseline corrected visual acuity of 20/40 to 20/320, and ≥1 ophthalmologist visit during follow-up. MAIN OUTCOME MEASURES: Intravitreal injections per study eye during the first 12 months; corrected visual acuity, change in corrected visual acuity from baseline, proportions of eyes with ≥10 or ≥15 approximate Early Treatment Diabetic Retinopathy Study letter gain/loss at 12 months; number of ophthalmologist visits. RESULTS: Over 12 months, mean number of ophthalmologist visits was 9.2; mean number of intravitreal injections was 3.1 (range, 1-12), with most eyes (68.6%) receiving ≤3 injections. At 12 months, mean corrected visual acuity change was +4.7 letters (mean 56.9 letters at baseline); proportions of eyes gaining ≥10 or ≥15 letters were 31.4% and 24.0%, respectively; proportions of eyes losing ≥10 or ≥15 letters were 10.8% and 8.3%, respectively. Eyes receiving adjunctive laser during the first 6 months (n = 33) showed similar change in corrected visual acuity to non-laser-treated eyes (n = 88) (+3.1 vs +5.3 letters at 12 months). CONCLUSIONS: DME patients receiving anti-VEGF therapy in clinical practice undergo less frequent monitoring and intravitreal injections, and achieve inferior vision outcomes to patients in landmark clinical trials.

Macula-Sparing Rhegmatogenous Retinal Detachment: Is Emergent Surgery Necessary?

The status of the macula is a significant factor in determining final visual outcomes in rhegmatogenous retinal detachment (RRD) and should be considered in the timing of surgical repair. Several studies have shown that macula-involving RRDs attain similar visual and anatomic outcomes when surgery is performed within seven days as compared to emergent surgery (within 24 hours). In contrast, surgery prior to macular detachment in macula-sparing RRDs generally yields the best visual outcomes. In the case of macula-sparing RRDs, it is not clear how long the macula may remain attached, therefore, standard practice dictates emergent surgery. Timing of presentation, examination findings, case complexity, co-existing medical conditions, surgeon expertise, and timing and quality of access to operating facilities and staff, however, should all be considered in determining whether a macula-sparing RRD requires immediate intervention or if equivalent visual and possibly better overall outcomes can be achieved with scheduled surgery within an appropriate time frame.

Clinical monitoring of patients with age-related macular degeneration treated with intravitreal bevacizumab or ranibizumab.

BACKGROUND AND OBJECTIVE: Patients with neovascular age-related macular degeneration (AMD) require frequent follow-up and regular anti-VEGF injections for optimal outcomes. Although studies suggest that injection frequency is suboptimal in clinical practice, monitoring frequency in this setting is unclear. This study evaluates annual monitoring patterns between 2008 and 2011. PATIENTS AND METHODS: This retrospective claims analysis included newly diagnosed neovascular AMD patients with at least one intravitreal bevacizumab or ranibizumab injection (8,811 and 2,877 patients, respectively). Patient monitoring and treatment patterns were assessed at 12-month intervals. RESULTS: From 2008 to 2010, the mean number of injections increased. In the 2010 cohort, among bevacizumab- and ranibizumab-treated patients, respectively, less than 23% and less than 40% had at least 10 ophthalmologist visits, and less than 4% and less than 21% had at least 10 optical coherence tomography scans. CONCLUSION: Patients with neovascular AMD in clinical settings during 2008 to 2011 were monitored less frequently and received fewer anti-VEGF injections than patients in major clinical trials, which may affect outcomes.

Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema.

PURPOSE: To examine the utilization of bevacizumab and ranibizumab and disease monitoring in patients with branch or central retinal vein occlusion (BRVO/CRVO) or diabetic macular edema (DME) in clinical practice. PATIENTS AND METHODS: This retrospective claims analysis included newly diagnosed patients with one or more bevacizumab or ranibizumab injections. Bevacizumab or ranibizumab utilization was assessed by year of first injection: 2008-2010 cohorts (12-month follow-up), January to June 2011 cohort (6-month follow-up). The main outcome measures were mean annual numbers of injections, ophthalmologist visits and optical coherence tomography examinations, and proportion of patients with additional laser or intravitreal triamcinolone (IVTA) use. RESULTS: A total of 885 BRVO, 611 CRVO, and 2,733 DME patients treated with bevacizumab were included, with too few ranibizumab-treated patients for meaningful analysis. Across the 2008, 2009, and 2010 cohorts, mean annual numbers of bevacizumab injections increased, but remained low (BRVO 2.5, 3.1, 3.3; CRVO 3.1, 3.1, 3.5; and DME 2.2, 2.5, 3.6, respectively); mean ophthalmologist visits ranged between 4.4 and 6.5, and mean optical coherence tomography examinations ranged between 3.1 and 3.9 across all conditions. A total of 42.0% of BRVO, 16.5% of CRVO, and 57.7% of DME patients received additional laser or IVTA therapy. The number of bevacizumab injections was positively associated with laser use in BRVO (3.3 versus 2.9, P<0.03), and with laser or IVTA use in DME (laser, 3.3 versus 2.7, P<0.03; IVTA, 3.3 versus 3.0, P<0.05). CONCLUSION: During the study period (2008-2011), bevacizumab was the main anti-VEGF therapy used in clinical practice for BRVO, CRVO, and DME. Patients treated with bevacizumab were monitored less frequently and received fewer injections than patients in major clinical trials of ranibizumab.

Clinical utilization of anti-VEGF agents and disease monitoring in neovascular age-related macular degeneration.

PURPOSE: To examine bevacizumab and ranibizumab utilization and disease monitoring patterns in patients with neovascular age-related macular degeneration (neovascular AMD) in clinical practice. DESIGN: Retrospective medical claims analysis. METHODS: Patients receiving ≥1 ranibizumab or bevacizumab injection during the 12 months after initial neovascular AMD diagnosis were included. Annual bevacizumab and/or ranibizumab injection utilization was assessed by year of first injection cohorts: 2006 and 2007 (received either agent because of billing code overlap), 2008, 2009, and January-June 2010 (received each agent). Outcome measures were time to first injection relative to neovascular AMD diagnosis and mean numbers of intravitreal injections, ophthalmologist visits, and optical coherence tomography (OCT) and fluorescein angiography (FA) examinations in 12 months. RESULTS: In the 2006 and 2007 cohorts (n = 8767), mean annual numbers of bevacizumab or ranibizumab injections were 4.7 and 5.0, respectively. Over 92% of patients in all cohorts received first treatment within 3 months of neovascular AMD diagnosis. In the 2008-2010 cohorts (n = 10 259), mean annual number of injections remained low (bevacizumab: 4.6, 5.1, and 5.5; ranibizumab: 6.1, 6.6, and 6.9), as did mean numbers of ophthalmologist visits (bevacizumab only) and OCT examinations (both agents), but there was no such trend in FA examinations. CONCLUSIONS: Compared with treatment paradigms validated by clinical trials published at the time, in clinical practice, patients with neovascular AMD received fewer bevacizumab or ranibizumab injections and less-frequent monitoring from 2006 to mid-2011. Factors contributing to this lower injection frequency and visual outcomes associated with reduced utilization need to be researched.