Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014).

OBJECTIVES: To assess the impact of CVS Health's discontinuation of tobacco sales on cigarette purchasing. METHODS: We used households' purchasing data to assess rates at which households stopped cigarette purchasing for at least 6 months during September 2014 to August 2015 among 3 baseline groups: CVS-exclusive cigarette purchasers, CVS+ (CVS and other retailers), and other-exclusive (only non-CVS retailers). In state-level analyses using retailers' point-of-sale purchase data, an interrupted time series compared cigarette purchasing before (January 2012 to August 2014) and after (September 2014 to April 2015) tobacco removal in 13 intervention states with CVS market share of at least 15% versus 3 control states with no CVS stores. RESULTS: Compared with other-exclusive purchasers, CVS-exclusive purchasers were 38% likelier (95% confidence interval = 1.06, 1.81) to stop cigarette purchasing after tobacco removal. Compared with control states, intervention states had a significant mean decrease of 0.14 (95% confidence interval = 0.06, 0.22) in packs per smoker per month. CONCLUSIONS: After CVS's tobacco removal, household- and population-level cigarette purchasing declined significantly. Private retailers can play a meaningful role in restricting access to tobacco. This highlights one approach to reducing tobacco use and improving public health.

Delayed opportunities for patient-provider communication about medication overuse headache: Mixed methods perspectives from patients and neurologists.

Objectives: Medication overuse headache (MOH) is a common, debilitating condition occurring when migraine patients overuse pain relief medications. We conducted a convergent mixed methods study examining patient-provider communication on MOH. Methods: Migraine patients were identified from one academic health center via electronic health records. Research staff recruited patients and administered a remote survey on MOH awareness, knowledge, and communication; descriptive and bivariate analyses were conducted. Neurologists from the same health center were invited to participate in qualitative interviews; analysis drew from the Rapid Identification of Themes from Audio Recordings procedures. A side-by-side comparison of results followed. Results: Participants included 200 patients and 13 neurologists. More than one third of patients (39.5 %) had never heard of 'medication overuse headache.' Among those who had, 38.4 % learned about MOH ≥ 5 years after their migraine diagnosis. Neurologists similarly reported limited patient awareness of MOH and suggested communication was provider-initiated, reactive to patient-reported symptoms and behaviors. Participants agreed MOH was described as a 'consequence' of frequent medication taking, though specific terminology varied with neurologists suggesting they choose terms they perceive to be easier to understand and less stigmatizing to patients. Neurologists felt they lacked effective patient education resources. Conclusions: Findings reveal delayed opportunities to inform patients about MOH. Standardized education supporting early preventive communication is needed, perhaps in primary care where many patients seek initial care for migraine symptoms.

Association between awareness and knowledge of medication-overuse headache with medication-taking behavior among adults with migraine.

Frequent use of pain relief medications among patients with migraine can result in disease worsening and medication-overuse headache (MOH), a painful and debilitating condition. We sought to conduct a cross-sectional survey among adult patients diagnosed with migraine to determine: 1) their awareness of MOH, and 2) their knowledge of the condition and its prevention, and 3) the association of these factors with actual use of pain relief medications. We recruited and interviewed 200 English-speaking adults with migraine who had a clinic visit with a neurologist or primary care provider within the past month. Patients were identified via an electronic health record query. Almost 40% of participants had never heard of the term 'medication-overuse headache.' In bivariate analyses, participants who were Black or Hispanic and those with limited health literacy were less likely to have heard of MOH. Participants scored an average of 2.1 (range: 0-3) on a MOH knowledge measure; older participants, those with limited health literacy, lower education, and little or no migraine-related disability demonstrated less knowledge. Almost a third (31.5%) of patients reported overusing pain relief medication and were at risk for MOH. Overuse was not significantly associated with MOH awareness, knowledge, or sociodemographic factors, but was related to greater migraine-related disability. Our findings suggest that patient awareness and knowledge of MOH is suboptimal, particularly among older adults, racial and ethnic minority groups, and those with limited health literacy. Interventions are needed to prevent MOH and better inform patients about risks associated with frequent use of pain relief medications.

The burden of hip osteoarthritis in the United States: epidemiologic and economic considerations.

Osteoarthritis (OA) is a common and disabling disease. Because of improved treatment of chronic diseases and lower mortality from infectious diseases, the US population is aging, and older Americans are living with disabling conditions, including hip OA. The projected number of older adults with arthritis or other chronic musculoskeletal joint symptoms is expected to nearly double, from 21.4 million in 2005 to 41.1 million by 2030. The burden of hip OA is increasing due to the aging population and the obesity crisis; as a result, the need for total hip arthroplasty (THA) is expected to grow 174%, to 572,000 primary THAs per year by 2030 in the United States. Prior projections appear to have underestimated the actual number of primary and revision THAs that are in demand.

Relationships between headache frequency, disability, and disability-related unemployment among adults with migraine.

BACKGROUND: Migraine is the second most common cause of disability worldwide. Understanding the relationship between migraine and employment status is critical for policymakers, as disability-related unemployment is associated with eligibility for private or governmental disability insurance payments and other associated support for those unable to work because of disability. OBJECTIVE: To assess the association between migraine frequency and selfreported employment status and overall disability in a US representative survey. METHODS: Using data from the 2019 National Health and Wellness Survey (NHWS) (Kantar Health), adults in the United States (aged 18-65 years) reporting at least 1 migraine day in the past 30 days were categorized by headache frequency: low-frequency episodic migraine (LFEM) (≤4 days/month), moderate-frequency EM (MFEM) (5-9 days/month), high-frequency EM (HFEM) (10-14 days/month), or chronic migraine (CM) (≥15 days/month). A control group of adults without migraine with similar baseline characteristics was identified by propensity score matching. Disability-related unemployment was defined as participants responding "short-term disability" or "long-term disability" to occupational status on the NHWS. The frequency of short- or long-term disability was then evaluated across headache frequency groups. In addition, participants were asked to assess migraine-related disability via the Migraine Disability questionnaire (MIDAS). RESULTS: A total of 1,962 respondents with LFEM, 987 with MFEM, 554 with HFEM, and 926 with CM were included in this analysis, along with 4,429 matched controls. Headache frequency was associated both with increased MIDAS score and with employment disability (P < 0.001); 12.3% (n = 114 of 926) of participants with CM reported employment disability, as did 4.4% (n = 86 of 1,962) of the LFEM group and 6.9% (n = 306 of 4,429) of matched controls. There was considerable discordance between the proportion of participants classified as disabled via MIDAS vs those reporting employment-related disability. CONCLUSIONS: More frequent migraine headaches are associated with a higher likelihood of self-reported short- and long-term employment disability and overall migraine-related disability, suggesting that health and economic policymakers must seek ways to maximize the employment opportunities for people living with migraine that may benefit from novel preventive treatments. DISCLOSURES: Robert E Shapiro is a research consultant for Eli Lilly and Lundbeck. Ashley A Martin and Martine C Maculaitis are employees of Cerner Enviza (formerly Kantar Health), which received payment from Lundbeck to conduct the research. Shiven Bhardwaj was an employee of Lundbeck at the time of study and manuscript development. Heather Thomson and Carlton Anderson are employees of Lundbeck. Steven M Kymes is an employee and stockholder of Lundbeck. Financial support for research conducted and manuscript preparation was provided by Lundbeck.

Cost-Utility Comparison of Bevacizumab and Aflibercept in the Treatment of Central or Hemiretinal Vein Occlusion in the SCORE2 Trial.

Importance: Retinal vein occlusion is the second most common retinal vascular disease. Bevacizumab was demonstrated in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) to be noninferior to aflibercept with respect to visual acuity in study participants with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) following 6 months of therapy. In this study, the cost-utility of bevacizumab vs aflibercept for treatment of CRVO is evaluated. Objective: To investigate the relative cost-effectiveness of bevacizumab vs aflibercept for treatment of macular edema associated with CRVO or HRVO. Design, Setting, and Participants: This economic evaluation study used a microsimulation cohort of patients with clinical and demographic characteristics similar to those of SCORE2 participants and a Markov process. Parameters were estimated and validated using a split-sample approach of the SCORE2 population. The simulated cohort included 5000 patients who were evaluated 100 times, each with a different set of characteristics randomly selected based on the SCORE2 trial. SCORE2 data were collected from September 2014 October 2019, and data were analyzed from October 2019 to July 2021. Interventions: Bevacizumab (followed by aflibercept among patients with a protocol-defined poor or marginal response to bevacizumab at month 6) vs aflibercept (followed by a dexamethasone implant among patients with a protocol-defined poor or marginal response to aflibercept at month 6). Main Outcomes and Measures: Incremental cost-utility ratio. Results: The simulation demonstrated that patients treated with aflibercept will have an expected cost $18 127 greater than those treated with bevacizumab in the year following initiation. When coupled with the lack of clinical superiority over bevacizumab (ie, patients treated with bevacizumab had a gain over aflibercept in visual acuity letter score of 4 in the treated eye and 2 in the fellow eye), these results demonstrate that first-line treatment with bevacizumab dominated aflibercept in the simulated cohort of SCORE2 participants. At current price levels, aflibercept would be considered the preferred cost-effective option only if treatment restored the patient to nearly perfect health. Conclusions and Relevance: While there will be some patients with CRVO-associated or HRVO-associated macular edema who will benefit from first-line treatment with aflibercept rather than bevacizumab, given the minimal differences in visual acuity outcomes and large cost differences for bevacizumab vs aflibercept, first-line treatment with bevacizumab is cost-effective for this condition.

The development of a decision analytic model of changes in mean deviation in people with glaucoma: the COA model.

PURPOSE: To create and validate a statistical model predicting progression of primary open-angle glaucoma (POAG) assessed by loss of visual field as measured in mean deviation (MD) using 3 landmark studies of glaucoma progression and treatment. DESIGN: A Markov decision analytic model using patient level data described longitudinal MD changes over 7 years. PARTICIPANTS: Patient-level data from the Collaborative Initial Glaucoma Treatment Study (n = 607), the Ocular Hypertension Treatment Study (OHTS; n = 148; only those who developed POAG in the first 5 years of OHTS) and Advanced Glaucoma Intervention Study (n = 591), the COA model. METHODS: We developed a Markov model with transition matrices stratified by current MD, age, race, and intraocular pressure categories and used a microsimulation approach to estimate change in MD over 7 years. Internal validation compared model prediction for 7 years to actual MD for COA participants. External validation used a cohort of glaucoma patients drawn from university clinical practices. MAIN OUTCOME MEASURES: Change in visual field as measured in MD in decibels (dB). RESULTS: Regressing the actual MD against the predicted produced an R(2) of 0.68 for the right eye and 0.63 for the left. The model predicted ending MD for right eyes of 65% of participants and for 63% of left eyes within 3 dB of actual results at 7 years. In external validation the model had an R(2) of 0.79 in the right eye and 0.77 in the left at 5 years. CONCLUSIONS: The COA model is a validated tool for clinicians, patients, and health policy makers seeking to understand longitudinal changes in MD in people with glaucoma.

Development of a decision-analytic model for the application of STR-based provenance testing of transrectal prostate biopsy specimens.

BACKGROUND: The diagnostic algorithm for most cancers includes the assessment of a tissue specimen by a surgical pathologist, but if specimen provenance is uncertain, the diagnostic and therapeutic process carries significant risk to the patient. Over the last decade, short tandem repeat (STR) analysis has emerged as a DNA-based method with clinical applicability for specimen identity testing (also known as specimen provenance testing). Although the clinical utility of identity testing using STR-based analysis has been demonstrated in many studies, its economic value has not been established. METHODS: We developed a decision-analytic model of the application of STR-based provenance testing of transrectal prostate biopsy specimens obtained as part of routine clinical care to rule out the presence of adenocarcinoma of the prostate, as compared with no STR-based testing. Using parameter values drawn from the published literature, the cost-effectiveness of STR-based testing was quantified by calculating the incremental cost-effectiveness ratio per quality-adjusted life-year gained. RESULTS: In comparison to the current standard practice of no identity testing, identity testing by STR-based analysis has an incremental cost-effectiveness ratio of $65,570 per quality-adjusted life-year gained at a testing cost of $618 per person. At a cost of $515 per person, identity testing would meet the conservative standard of $50,000 per quality-adjusted life-year. At a test cost of $290 per person, identity testing would be cost saving. CONCLUSION: Given the rapidly declining pricing of STR-based identity testing, it is likely that testing to confirm the identity of positive prostate biopsy samples will be a cost-effective method for preventing treatment errors stemming from misidentification. Studies to formally establish the frequency of specimen provenance errors in routine clinical practice would therefore seem justified.

Real-world droxidopa or midodrine treatment persistence in patients with neurogenic orthostatic hypotension or orthostatic hypotension.

BACKGROUND: Neurogenic orthostatic hypotension (nOH) is a subtype of orthostatic hypotension (OH) observed in the presence of neuropathy and is associated with increased risk of falling, impaired function, and poor quality of life. Droxidopa and midodrine are approved in the United States to treat symptomatic nOH and OH in adults, respectively. In this study, we compared the treatment persistence of droxidopa and midodrine. METHODS: A retrospective analysis of patients prescribed either droxidopa or midodrine was conducted using the Symphony Health Solutions database (Symphony Health Solutions, Phoenix, AZ, USA). Inclusion criteria were (1) a pharmacy insurance claim in at least 16 consecutive quarters from mid-2014 to 2018 and (2) an active prescription for droxidopa or midodrine of ≥30 days' duration during that period. Treatment persistence was defined as the time to the first break in drug coverage of ≥45 days and was capped at 365 days. RESULTS: Data from 2305 patients who received droxidopa and 117,243 patients who received midodrine were included in this analysis. Median (95% CI) treatment persistence was significantly longer in the droxidopa cohort versus the midodrine cohort (303 [274-325] vs 172 [169-176] days; P < 0.001). After adjustment for confounding factors, patients using droxidopa monotherapy (i.e., without any concomitant midodrine and/or fludrocortisone use) were 16% more likely to be persistent at any time point than patients using midodrine (P < 0.001). CONCLUSIONS: In this real-world data analysis, patients using droxidopa without concomitant medications for OH were more likely to remain on treatment than patients on midodrine.

A modelling approach to estimate the prevalence of treatment-resistant schizophrenia in the United States.

INTRODUCTION: Schizophrenia is a condition that places a significant burden on individuals with the condition, their family, and society. A large proportion of those treated for schizophrenia do not experience treatment response and are referred to as having "treatment-resistant schizophrenia" (TRS). Expert opinion has long held that the prevalence of TRS among individuals with schizophrenia is 30%, but the basis of this estimate is unclear. This article presents a model developed for estimating the prevalence of TRS in the United States 2014. METHODS: An incidence-prevalence-mortality model was developed to estimate the prevalence of TRS in the United States. The model was populated with data from public health agencies and published literature. Prevalence in 2014 was modelled using a Markov cohort simulation for each birth cohort between 1930 to 2014. RESULTS: Using different scenarios for baseline incidence, relative risks of mortality, it was estimated that approximately 22% of individuals with schizophrenia would be considered treatment-resistant in 2014. DISCUSSION: The results suggests that prevalence of TRS may be somewhat lower than the 30% often reported, however this is highly dependent on the definition of treatment resistance. Methods such as this may help answer epidemiological and health policy questions as well as test the influence of key underlying assumptions.

The cost-effectiveness of treatment of age-related macular degeneration: a review.

Age-related macular degeneration (AMD) is a disease of the retina, most often seen among people over the age of 50. The disease is typically manifested by the loss of central vision and as such represents a major threat to the quality of life to those suffering with it. This report reviewed the evidence concerning the economic impact of macular degeneration in the developed world, examining reports on direct and indirect medical costs, as well as those that have attempted to estimate non-health care costs. It also aimed to review reports of the cost-effectiveness of treatment of the disease, examining nutritional supplements, photodynamic therapy, and anti-VEGF treatments.

Six-Month Use of Droxidopa for Neurogenic Orthostatic Hypotension.

BACKGROUND: Droxidopa is approved for adult patients with symptomatic neurogenic orthostatic hypotension (nOH); there is limited information regarding effects on symptoms, outcomes, and quality of life (QOL) beyond two weeks of treatment. OBJECTIVE: Examine the real-world experience of patients taking droxidopa after six months of treatment. METHODS: This non-interventional, US-based, prospective cohort study utilized a pharmacy hub, identifying patients who recently started droxidopa for nOH treatment. Questionnaires for fall frequency and other patient-reported outcomes (PROs) were completed at baseline and one, three, and six months following droxidopa initiation. RESULTS: 179 enrolled patients completed baseline surveys. Droxidopa continuation rates were high at months one, three, and six (87%, 79%, and 75%, respectively). From baseline to month one, there was significant reduction in the proportion of patients reporting falling at least once (54.1% vs. 43.0%; P = 0.0039), with similar observations at month three (52.9% vs. 44.5%; P = 0.0588) and month six (51.4% vs. 40.0%; P = 0.0339). Significant improvements from baseline to month one were observed and maintained at months three and six for most PROs, including the Orthostatic Hypotension Symptom Assessment Item 1, Short Falls Efficacy Scale-International, Sheehan Disability Scale, Physical Component of the 8-item Short-Form Health Survey, and Patient Health Questionnaire-9. CONCLUSIONS: In this non-interventional prospective study, fewer nOH patients reported falling after one, three, and six months of droxidopa treatment. Further, improvements reported in nOH symptoms, physical function, and QOL measures were maintained for six months following treatment initiation. Results from randomized clinical trials are required to validate the findings.

A comparison of the diagnostic accuracy of 18F-FDG PET and CT in the characterization of solitary pulmonary nodules.

UNLABELLED: CT and PET are widely used to characterize solitary pulmonary nodules (SPNs). However, most CT accuracy studies have been performed with outdated technology and methods, and previous PET studies have been limited by small sample sizes and incomplete masking. Our objective was to compare CT and PET accuracy in veterans with SPN. METHODS: Between January 1999 and June 2001, we recruited 532 participants with SPNs newly diagnosed on radiography and untreated. The SPNs were 7-30 mm. All patients underwent (18)F-FDG PET and CT. A masked panel of 3 PET and 3 CT experts rated the studies on a 5-point scale. SPN tissue diagnosis or 2-y follow-up established the final diagnosis. RESULTS: A definitive diagnosis was established for 344 participants. The prevalence of malignancy was 53%. The average size was 16 mm. Likelihood ratios (LRs) for PET and CT results for combined ratings of either definitely benign (33% and 9% of patients, respectively) or probably benign (27% and 12%) were 0.10 and 0.11, respectively. LRs for PET and CT results for combined ratings of indeterminate (1% and 25%), probably malignant (21% and 39%), or definitely malignant (35% and 15%) were 5.18 and 1.61, respectively. Area under the receiver operating characteristic curve was 0.93 (95% confidence interval, 0.90-0.95) for PET and 0.82 (95% confidence interval, 0.77-0.86) for CT (P < 0.0001 for the difference). PET inter- and intraobserver reliability was superior to CT. CONCLUSION: Definitely and probably benign results on PET and CT strongly predict benign SPN. However, such results were 3 times more common with PET. Definitely malignant results on PET were much more predictive of malignancy than were these results on CT. A malignant final diagnosis was approximately 10 times more likely than a benign final diagnosis in participants with PET results rated definitely malignant.

The impact of anchor point on utilities for 5 common ophthalmic diseases.

PURPOSE: To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. DESIGN: Cross-sectional observational preference study. PARTICIPANTS: We included 434 patients: 58 with diabetic retinopathy, 99 with glaucoma, 44 with age-related macular degeneration (AMD), 124 with cataract; 109 with refractive error. TESTING: Standard gamble utilities were estimated using a computer-based preference assessment interview platform. MAIN OUTCOME MEASURES: Standard gamble utilities, a quality-of-life measure that examines the willingness to accept a risk of death or unilateral blindness in return for perfect health or perfect vision. RESULTS: Using the standard policy scale, where health equivalent to death is 0 and perfect health is 1, participants with asymptomatic diabetic retinopathy had a utility of 0.93. By comparison, symptomatic diabetics had a further utility loss of 0.14. Asymptomatic glaucoma participants had a utility of 0.92 with a decrease of 0.03 for early field loss and a further decrease of 0.03 with central field loss. Participants with AMD who had > or =20/100 better-eye visual acuity reported a utility of 0.89, whereas those with more severe AMD reported 0.76. However, neither clinical cataract opacity score nor refractive error correlated with utility. Adjustment for age and comorbidity did not alter these relationships. For the same participants, utilities measured with different anchor points-monocular blindness as 0 and perfect vision as 1-were lower, especially among participants with increased disease severity. The difference between utility assessed on this perfect vision-blindness scale and the perfect health-death scale ranged from 0.04 for those with severe refractive error to 0.19 for symptomatic diabetics and 0.37 for those with severe AMD. CONCLUSIONS: This paper elicits utilities with different anchor points from a previously unreported sample of 434 patients. Lower utility scores normally imply greater benefit with successful treatment or prevention of disease, but switching from the conventional policy scale to the perfect vision scale also consistently results in lower scores. Because most previous ophthalmic studies have used perfect vision as the upper anchor, the resulting utilities may not have been accurate.

Changes in the quality-of-life of people with keratoconus.

PURPOSE: The Collaborative Longitudinal Evaluation of Keratoconus Study (CLEK) previously showed that people with keratoconus report significantly impaired vision-related quality-of-life (V-QoL), as measured on the National Eye Institute Visual Function Questionnaire (NEI-VFQ), similar to that of people who have severe macular degeneration. For this study, we evaluated changes that occurred in V-QoL over seven years of follow-up. DESIGN: In this prospective cohort study of 1,166 participants followed up for seven years, we estimated change in V-QoL by projecting the slope of a minimum of three reports on 11 scales of the NEI-VFQ. Correlation with clinical indicators was evaluated, and differences were assessed between those who had clinically significant changes in clinical factors and those who did not. Logistic regression was used to assess factors associated with a decline in 10 points or more in a scale score over seven years. RESULTS: All scales showed modest decline except ocular pain and mental health. Baseline factors were not associated with longitudinal change in NEI-VFQ scores. A 10-letter decline in high-contrast binocular visual acuity or a 3.00-diopter increase in corneal curvature were associated with significantly larger declines in V-QoL. In multivariate analysis, these factors also were found to be associated with a 10-point decline in NEI-VFQ scale scores. CONCLUSIONS: Keratoconus is associated with significantly impaired V-QoL that continues to decline over time. For a substantial plurality of patients, these declines are significant.

Association of complement factor H and LOC387715 genotypes with response of exudative age-related macular degeneration to intravitreal bevacizumab.

PURPOSE: To investigate whether there is an association between complement factor H (CFH) or LOC387715 genotypes with response to treatment with intravitreal bevacizumab for exudative age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. PARTICIPANTS: The study cohort consisted of 86 patients being treated for neovascular AMD with bevacizumab alone. METHODS: Genotype determination for the CFH Y402H and LOC387715 A69S polymorphisms was performed by allele-specific digestion of polymerase chain reaction products. All patients were treated with 1.25 mg intravitreal bevacizumab at 6-week intervals until choroidal neovascularization was no longer active. MAIN OUTCOME MEASURES: CFH Y402H and LOC387715 A69S polymorphisms. Choroidal neovascular lesion characteristics were ascertained by fluorescein angiography. Snellen visual acuity (VA) was measured before and after treatment. RESULTS: For the CFH Y402H polymorphism, patients with the CFH TT genotype had the largest choroidal neovascular lesions (P = 0.02). With treatment, VA improved from 20/248 to 20/166 for the CFH TT genotype and from 20/206 to 20/170 for the TC genotype, but fell from 20/206 to 20/341 for the CFH CC genotype (P = 0.016). Only 10.5% of patients with the CFH CC genotype demonstrated improved VA with treatment, compared with 53.7% of CFH TT and TC genotypes (P = 0.004). For the LOC387715 A69S variant, patients with the TT genotype had the largest choroidal neovascular lesions (P = 0.012). There was no significant difference in response to bevacizumab treatment according to LOC387715 genotype. CONCLUSIONS: The AMD-associated CFH Y402H and LOC387715 A69S variants were associated with differences in choroidal neovascular lesion size in this study. Patients with the CFH CC genotype fared significantly worse with intravitreal bevacizumab than did those with the CFH TC and TT genotypes, suggesting a potential pharmacogenetic relationship. Prospective studies to confirm or refute this observation should be considered.

Clinical phenotypes associated with the complement factor H Y402H variant in age-related macular degeneration.

PURPOSE: To determine whether the complement factor H (CFH) Y402H variant is associated with specific age-related macular degeneration (AMD) clinical phenotypes. DESIGN: Retrospective, case-control study. METHODS: One hundred and eighty-eight white subjects with AMD and 189 control subjects were genotyped for the T-to-C polymorphism in exon 9 of the CFH gene by restriction-fragment length analysis and deoxyribonucleic acid (DNA) sequencing using genomic DNA from mouthwash samples. AMD phenotypes were characterized by clinical examination, fundus photography, and fluorescein angiography. RESULTS: Heterozygosity for the at-risk genotype (TC) increased the likelihood for AMD 2.1-fold (95% confidence interval [CI], 1.3 to 3.3), whereas homozygosity for the genotype (CC) increased the likelihood for AMD 6.5-fold (95% CI, 3.4 to 12.5) in our population. The C allele was associated significantly with predominantly classic choroidal neovascularization (odds ratio [OR], 2.01; 95% CI, 1.34 to 3.30). Neovascular lesion size was similar among the three genotypes (P = .67). CONCLUSIONS: The Y402H CFH variant carried a significantly increased risk for developing AMD in our population. Genotype and phenotype correlations regarding choroidal neovascular lesion type were observed.