Canadian Treat-and-Extend Analysis Trial with Ranibizumab in Patients with Neovascular Age-Related Macular Disease: One-Year Results of the Randomized Canadian Treat-and-Extend Analysis Trial with Ranibizumab Study.

PURPOSE: To compare the efficacy of ranibizumab using a treat-and-extend (T&E) regimen with monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD). DESIGN: Prospective, randomized, open-label, multicenter, noninferiority, postauthorization study. PARTICIPANTS: Treatment-naive patients with choroidal neovascularization secondary to AMD. METHODS: Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab at a dose of 0.5 mg in either a T&E or monthly dosing regimen. The noninferiority of T&E compared with the monthly dosing regimen was to be shown using a margin of 5 letters in best-corrected visual acuity (BCVA) improvement. MAIN OUTCOME MEASURES: Mean change in BCVA in Early Treatment Diabetic Retinopathy Study letters from baseline to month 12. RESULTS: Baseline and 12-month visual acuity data are available for 526 patients (T&E, n = 268; monthly, n = 258). At baseline, mean age was 78.8 years (standard deviation [SD], 7.8 years), 60.3% were women, and 94.3% were white. No significant between-group baseline differences were observed. The primary outcome of noninferiority regarding visual acuity was met with mean BCVA improvement of 8.4 letters (SD, 11.9 letters) and 6.0 letters (SD, 11.9 letters; P = 0.017) in the T&E and monthly regimens, respectively, with a between-group mean difference of 2.38 letters (95% confidence interval, 0.32-4.45 letters). Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E versus monthly dosing (9.4 and 11.8 injections, respectively), with a mean difference of -2.46 injections (95% confidence interval, -2.68 to -2.23 injections). CONCLUSIONS: The 12-month results of this 2-year study demonstrated that regarding visual outcomes, the T&E regimen was noninferior to a monthly dosing regimen. Similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections.

Diabetic Disease of the Eye in Canada: Consensus Statements from a Retina Specialist Working Group.

Despite advances in systemic care, diabetic disease of the eye (DDE) remains the leading cause of blindness worldwide. There is a critical gap of up-to-date, evidence-based guidance for ophthalmologists in Canada that includes evidence from recent randomized controlled trials. Previous guidance has not always given special consideration to applying treatments and managing DDE in the context of the healthcare system. This consensus statement aims to assist practitioners in the field by providing a spectrum of acceptable opinions on DDE treatment and management from recognized experts in the field. In compiling evidence and generating consensus, a working group of retinal specialists in Canada addressed clinical questions surrounding the four themes of disease, patient, management, and collaboration. The working group reviewed literature representing the highest level of evidence on DDE and shared their opinions on topics surrounding the epidemiology and pathophysiology of diabetic retinopathy and diabetic macular edema; diagnosis and monitoring; considerations around diabetes medication use; strategic considerations for management given systemic comorbidities, ocular comorbidities, and pregnancy; treatment goals and modalities for diabetic macular edema, non-proliferative and proliferative diabetic retinopathy, and retinal detachment; and interdisciplinary collaboration. Ultimately, this work highlighted that the retinal examination in DDE not only informs the treating ophthalmologist but can serve as a global index for disease progression across many tissues of the body. It highlighted further that DDE can be treated regardless of diabetic control, that a systemic approach to patient care will result in the best health outcomes, and prevention of visual complications requires a multidisciplinary management approach. Ophthalmologists must tailor their clinical approach to the needs and circumstances of individual patients and work within the realities of their healthcare setting.

Sequential measurement of the neurosensory retina in hypertensive disorders of pregnancy: a model of microvascular injury in hypertensive emergency.

Optical coherence tomography of the eye suggests the retina thins in normal pregnancy. Our objectives were to confirm and extend these observations to women with hypertensive disorders of pregnancy (HDP). Maternal demographics, clinical/laboratory findings and measurements of macular thickness were repeatedly collected at gestational ages <20 weeks, 20-weeks to delivery, at delivery and postpartum. The primary outcome was the change in macular thickness from non-pregnant dimensions in women with incident HDP compared to non-hypertensive pregnant controls. Secondary outcomes were the relationship(s) between mean arterial pressure (MAP) and macular response. Data show macular thicknesses diminished at <20 weeks gestation in each of 27 pregnancies ending in HDP (mean 3.94 µm; 95% CI 4.66, 3.21) and 11 controls (mean 3.92 µm; 5.05, 2.79; P < 0.001 versus non-pregnant dimensions in both; P = 0.983 HDP versus controls). This thinning response continued to delivery in all controls and in 7 women with HDP superimposed on chronic hypertension. Macular thinning was lost after 20 weeks gestation in the other 20 women with HDP. MAP at loss of macular thinning in women without prior hypertension (n = 12) was identical to MAP at enrollment. However, mean MAP subsequently rose 19 mmHg (15, 22) leading to de novo HDP in all 12 women. Loss of thinning leading to a rise in MAP was also observed in 8 of 15 women with HDP superimposed on chronic hypertension. We conclude the macula thins in most women in early pregnancy. Those who lose this early macular thinning response often develop blood pressure elevations leading to HDP.

Ocriplasmin versus vitrectomy for the treatment of macular holes.

OBJECTIVE: To compare the anatomical and visual outcomes of patients with bilateral macular holes (MH) who have been treated with pars plana vitrectomy in one eye and intravitreal ocriplasmin in the fellow eye. DESIGN: Multicentre, retrospective case series. PARTICIPANTS: Twenty-two eyes of 11 patients with bilateral MH treated with vitrectomy in one eye and ocriplasmin in the other were included. Patients were followed-up by 5 vitreoretinal surgeons from 3 retinal practices in Canada. METHODS: All charts were reviewed for data collection, and optical coherence tomography (OCT) scans pre- and posttreatment were evaluated. RESULTS: MH closed primarily in 36.4% (n = 4) of the ocriplasmin-treated eyes and in 90.9% (n = 10) of the vitrectomy-treated eyes (p = 0.031). The 4 successfully treated ocriplasmin MH were preceded by a vitreomacular traction (VMT) release. Three additional ocriplasmin-treated eyes achieved a VMT release without MH closure. All persistent MH (100%) closed with subsequent vitrectomy, with no significant difference in final best-corrected visual acuity (BCVA) between those who achieved MH closure with primary or secondary interventions (p = 0.073). Final BCVA improved from logMAR 0.85 ± 0.34 to 0.37 ± 0.22 (p = 0.005) in the vitrectomy eyes and from 0.56 ± 0.28 to 0.28 ± 0.16 (p = 0.009) in the ocriplasmin eyes, with no significant difference in final BCVA between treatments (p = 0.306). Postoperative ellipsoid zone disruption persisted more frequently in vitrectomy-treated eyes. CONCLUSION: Both procedures were associated with improved visual outcomes, but eyes initially treated with vitrectomy had a higher primary MH closure rate. On OCT, patients had more outer structural changes in vitrectomy eyes than in ocriplasmin eyes.