Importance of Anatomical Efficacy for Disease Control in Neovascular AMD: An Expert Opinion.

BACKGROUND: Neovascular age-related macular degeneration (nAMD) presents a significant treatment burden for patients, carers and medical retina services. However, significant debate remains regarding how best to manage nAMD when assessing disease activity by optical coherence tomography (OCT), and particularly the significance of different types of fluid and how the understanding of anatomical efficacy can influence treatment strategies. This article provides opinion on the practical implications of anatomical efficacy and significance of fluid in the management of nAMD and proposes recommendations for healthcare professionals (HCPs) to improve understanding and promote best practice to achieve disease control. METHODS: An evidence-based review was performed and an expert panel debate from the Retina Outcomes Group (ROG), a forum of retinal specialists, provided insights and recommendations on the definition, role and practical implications of anatomical efficacy and the significance of fluid at the macula in the management of nAMD. RESULTS: The ROG has developed recommendations for achieving disease control through a zero-tolerance approach to the presence of fluid in nAMD as patients who avoid fluctuations in fluid at the macula have better visual outcomes. Recommendations cover five key areas: service protocol, training, regimen, multidisciplinary teams and engagement. This approach facilitates more standardised protocol-based treatment strategies. CONCLUSIONS: Targeting a fluid-free macula and aiming for disease control are essential to improve outcomes. As new therapies and technologies become available, drying the macula and maintaining disease control will become even more achievable. The outlined recommendations aim to promote best practice among HCPs and medical retina services to improve patient outcomes.

Initiation and maintenance of a Treat-and-Extend regimen for ranibizumab therapy in wet age-related macular degeneration: recommendations from the UK Retinal Outcomes Group.

The treatment of neovascular (wet) age-related macular degeneration (AMD) with ranibizumab is now very well established in terms of efficacy and safety. Recent clinical trials and real-world studies have demonstrated the advantages of a Treat-and-Extend (T&E) regimen, and many hospital departments are now in the process of adopting this new regimen in favor of the pro re nata regimen for initiating and continuing ranibizumab therapy for patients with wet AMD. The comprehensive spectrum of issues related to implementation of the regimen is covered qualitatively in ten didactic topics provided by a group of clinicians with direct experience of this regimen in their department. The topics include definition, new and previously treated eyes, management of high-frequency injections, maximum extensions, discontinuing T&E, bilateral cases, clerical, audit, and patient counseling. This article aims to provide a useful resource for the implementation of the T&E regimen. A quantitative summary of the visual outcomes in key publications is also provided in this article. This article should be a valuable resource for staff training.

24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting.

BACKGROUND: To evaluate the clinical effectiveness and analyze the outcomes of a treat-and-extend (T&E) treatment regimen with ranibizumab for wet age-related macular degeneration (ARMD) in real life clinical settings over the first 2 years (24 months) of treatment. METHODS: Retrospective analysis of visual acuity, spectral domain optical coherence tomography (SD-OCT) parameters and treatment burden data of 56 eyes of 54 unselected treatment naive patients diagnosed with exudative ARMD. Monthly injections were offered until no signs of disease activity such as intra-retinal (IRF) or sub-retinal fluid (SRF) were evident on SD-OCT, followed by a gradual extension of the treatment interval by 2 weeks until a maximum of 12 weeks. RESULTS: The study met its main objective, demonstrating a mean best-corrected visual acuity gain of 8.3 letters (mean 68.8 ± 11) at month 12 and 5.2 letters (mean 65.7 ± 12.3) at 24 months compared to baseline (mean 60.5 ± 8.9). Anatomical improvement was also documented with a mean reduction of central retinal thickness by 139.7 µm at 24 months (244.9 ± 48.3) compared to baseline (384.6 ± 154.9). Forty-seven eyes (83.9% N = 56) gained vision or preserved baseline vision with 23 eyes (41.1%) gaining 10 letters or more at month 12. Out of the 46 eyes that completed 24 months of treatment and monitoring, 27 (58.7% N = 46) kept a BCVA above baseline with 18 of those (39% N = 46) maintaining a 10-letter gain throughout the 24 months. Six eyes (13% N = 46) lost more than 10 letters by month 24. The mean number of injections was 12.1 ± 2.8 over the 24-month period. Twenty-seven eyes (55.1% N = 56) achieved a treatment interval of 10 weeks or more at month 12, while the respective number at month 24 was 20 eyes (43.4% N = 46) in addition though to four more patients (8.7% N = 46) who were not receiving injections at month 24 since they were placed on a Monitor & Extend regime. CONCLUSIONS: This is the first UK real-life study of a T&E treatment protocol with ranibizumab for exudative ARMD in a 24-month period and suggests that such a regimen is clinically effective and can achieve favourable outcomes with a significant reduction of the treatment burden compared to monthly PRN.

Incidence of Retinal Pigment Epithelial Tears and Associated Risk Factors After Treatment of Age-Related Macular Degeneration with Intravitreal Anti-VEGF Injections.

PURPOSE: To study the incidence and risk factors for retinal pigment epithelium tears following intravitreal anti-vascular endothelial growth factor (VEGF) injections. METHODS: Retrospective longitudinal study. 4027 intravitreal anti-VEGF injections in 628 patients (676 eyes) for choroidal neovascularisation associated with age related macular degeneration in a period of 18 months were studied. RESULTS: Seventeen patients (mean age 83.95±5.84) developed retinal pigment epithelium tears. The incidence rate was 0.4%. Fibrovascular pigment epithelium detachment (PED) was previously observed in all cases. In 88 % (15/17) of AMD patients that had a RPE tear, PED height was found to be less than 400 microns at presentation. In 5 of 7 patients with RPE tear grade <4, continuing of anti-VEGF treatment resulted to improvement of visual acuity. CONCLUSION: Critical risk factors for RPE tears are presence of PED as well as advanced age. Visual improvement appears to depend more on the extent and location of the RPE tear and less on the PED height.

Dexamethasone intravitreal implant for idiopathic retinal vasculitis, aneurysms, and neuroretinitis.

PURPOSE: To present the short-term favorable clinical results with the dexamethasone intravitreal implant in a patient with florid idiopathic retinal vasculitis, aneurysms, and neuroretinitis syndrome (IRVAN).
 METHODS: A 26-year-old man presented with significant bilateral deterioration of vision due to vitreous hemorrhage and neuroretinitis with a background of vasculitis and neovascularization. The patient was initially treated with high doses of oral steroids (80 mg prednisolone), which were gradually tapered, and also received extensive argon laser photocoagulation in ischemic areas in both eyes. Despite vigorous treatment and an initial positive response to treatment, pars plana vitrectomy was eventually needed to address the recurrent vitreous hemorrhages in the left eye. Consequently, visual acuity improved from 0.1 to 0.2 (Snellen) and there was no relapse of vitreous hemorrhage. Persistent macular edema was noted, however, and it was decided to treat with a dexamethasone 0.7 mg intravitreal implant.
 RESULTS: Following the dexamethasone implant OS, visual acuity improved significantly from 0.2 to 0.5 (Snellen), the patient reported much less distortion, and there was marked reduction in central retinal thickness from 467 to 234 microns. The patient remains in remission without any exudation in the macula at 4 months follow-up.
 CONCLUSION: Dexamethasone 0.7 mg intravitreal implant appears to be a safe and effective solution in the treatment of macular edema in patients with IRVAN syndrome and could possibly be a treatment option for other cases of inflammatory induced macular edema.

Tear of Retinal Pigment Epithelium following YAG Laser Posterior Capsulotomy in a Patient on Anti-VEGF Treatment for AMD: Six Months' Follow-Up.

PURPOSE: To present a rare case of retinal pigment epithelium (RPE) rupture following YAG laser posterior capsulotomy (YAG PC) in a patient with exudative age-related macular degeneration (AMD). MATERIALS AND METHODS: An 85-year-old pseudophakic male patient on ranibizumab 0.5 mg/0.05 ml treatment due to exudative AMD received YAG PC for dense posterior capsule opacification (PCO) in his right eye. The patient had received his last intravitreal ranibizumab injection 3 months before YAG PC; his macula appeared stable on fundoscopy and optical coherence tomography scans at repeated visits, but his vision deteriorated to counting fingers due to PCO. RESULTS: Following left eye posterior YAG PC, his best-corrected visual acuity (BCVA) improved to 6/12 (Snellen chart). Despite satisfactory visual results, the patient developed a parafoveal inferotemporal RPE rupture. A decision for further treatment with ranibizumab (0.5 mg/0.05 ml) intravitreal injections was made. After a total of 7 injections, the patient was clinically stable and his BCVA was 6/18 (Snellen chart). CONCLUSIONS: RPE rupture is a well-known, serious complication in patients with exudative AMD, which often has devastating results on patients' vision. Offering YAG PC to those patients could lead to a rupture of the RPE even in cases which appear to be stable and well controlled. Clinicians should be aware of this complication and inform the patients accordingly.

Intravitreal ranibizumab in the treatment of butterfly-shaped pattern dystrophy associated with choroidal neovascularization: a case report.

PURPOSE: To present and document the effectiveness of intravitreal ranibizumab in the treatment of patients with choroidal neovascularization due to butterfly-shaped pattern dystrophy (PD) of the macula. METHODS: Three intravitreal ranibizumab injections of 0.5 mg/0.05 ml in monthly intervals were given to a patient with a previously diagnosed butterfly-shaped PD who subsequently developed subfoveal choroidal neovascularization on the right eye. The patient had previously received a combination of verteporfin/photodynamic therapy for a juxtafoveal choroidal neovascular membrane on the left eye. RESULTS: At the end of the treatment course, there was significant improvement of the patient's vision and the appearance of the macula on optic coherence tomography and fluorescein angiography. Best-corrected visual acuity improved from 6/12 to 6/6 and retinal thickness at the macula decreased from 323 to 247 µm. No subretinal fluid remained. The patient is clinically stable over a 12-month follow-up period. CONCLUSIONS: Intravitreal ranibizumab seems to be an effective and safe option for the treatment of subfoveal choroidal neovascularization in patients with butterfly-shaped PD.