Efficacy of Macular Hole Surgery in Patients with Idiopathic Macular Telangiectasia Type 2.

PURPOSE: To compare visual acuity (VA) and OCT outcomes in patients with idiopathic macular telangiectasia (IMT) type 2 who underwent pars plana vitrectomy (PPV) surgery for full-thickness macular holes (FTMHs) versus those who elected to be medically managed (MM) without surgery. DESIGN: Comparative retrospective case series. PARTICIPANTS: Patients with IMT type 2 and FTMH. METHODS: We reviewed records within an 11-year period and collected data on VA, OCT changes, development of choroidal neovascularization, and length of follow-up. The VA measurements were standardized from Snellen to logarithm of the minimum angle of resolution units for statistical analysis. Two-sample t tests were used to analyze VA data. OCT changes were assessed by a single masked retinal specialist. RESULTS: There were 12 eyes in the PPV group and 26 eyes in the MM group. There was no statistically significant VA improvement in either group between initial VA recording and last follow-up. The PPV group had no significant change in VA between the preoperative visit and the visits at 3 or 12 months. OCT scans improved by 1 step in 10 patients in the PPV group. None of the patients in the MM group had OCT improvement. Choroidal neovascularization developed in 1 eye in the PPV group and 5 eyes in the MM group. CONCLUSIONS: There was no significant change in VA in patients who opted to have PPV to treat their IMT type 2 and FTMH compared with those who did not undergo surgery. OCT scans improved by qualitative judgment in patients who underwent surgery compared with those who opted for medical management.

Effect of Regulatory Requirement for Patient-Specific Prescriptions for Off-Label Medications on the Use of Intravitreal Bevacizumab.

IMPORTANCE: Requirements regulating pharmaceutical prescriptions can affect physicians' choice of therapy in a clinical setting. OBJECTIVE: To evaluate the change in bevacizumab use after the regulatory requirement for patient-specific prescriptions (PSPs) for off-label medications in Ohio. DESIGN, SETTING, AND PARTICIPANTS: This study retrospectively reviewed the aggregate data from the billing records of patients receiving 1.25-mg injections of bevacizumab, 0.3- or 0.5-mg injections of ranibizumab, or 2.0-mg injections of aflibercept for age-related macular degeneration or diabetic macular edema in a 9-member retinal specialty private practice. The review assessed 4488 intravitreal injections in the 3-month period before (May 1 to July 30, 2012) and 5253 injections in the 3-month period after (May 1 to July 30, 2013) the Ohio Board of Pharmacy's requirement of PSPs for bevacizumab. Relative proportions of the drugs used for intravitreal injections were calculated and frequencies were compared. A Likert scale survey was conducted among the 9 physicians to identify reasons for their change in prescription of bevacizumab. The survey inquired about (1) the burden of PSPs, (2) concern about differences in efficacy, and (3) concern about differences in safety. MAIN OUTCOMES AND MEASURES: Difference in drug use before and after the PSP requirement for bevacizumab and the physicians' reasons for change in their drug use. RESULTS: Bevacizumab use decreased from 2752 of 4488 pre-PSP injections (61.3%) to 1503 of 5253 post-PSP injections (28.6%), a change of -32.7% (95% CI, -34.6% to -30.8%; P < .001). Use of 0.5-mg ranibizumab injections increased from 1122 of 4488 pre-PSP injections (25.0%) to 1838 of 5253 post-PSP injections (35.0%), a change of 10.0% (95% CI, 8.2% to 11.8%; P < .001). Use of 0.3-mg ranibizumab injections increased from 0 of 4488 (before US Food and Drug Administration approval) to 429 of 5253 post-PSP injections (8.2%), a change of 8.2% (95% CI, 7.4% to 8.9%; P < .001). Use of aflibercept injections increased from 614 of 4488 pre-PSP injections (13.7%) to 1483 of 5253 post-PSP injections (28.2%), a change of 14.6% (95% CI, 13.0%-16.1%; P < .001). In the survey of the 9 physicians concerning their reasons for decreased use of bevacizumab, 7 (78%) strongly agreed and 1 (11%) agreed that the burden of PSPs changed their choice of drug used for injection. CONCLUSIONS AND RELEVANCE: Use of bevacizumab was reduced by 32.7% 1 year after the regulatory requirement for PSPs for compounded (repackaged) medications. This change seemed to have more association with the requirement for PSPs than with a known change in efficacy or safety concerns. Although this study was based on a single US practice, regulation of repackaged medication for safety concerns should also consider the evaluation of treatment burden, cost, and adherence.