Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial.

IMPORTANCE: Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. METHODS: A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). RESULTS: Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2-12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7-9) injections, with a significant reduction of -93.0 [-154.0, -44.0] µm in central macular thickness (p < 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2-11] vs. 5 [2-13] letters (p = 0.98)), number of IVAIs (8.5 [7-9] vs. 8 [7-9] (p = 0.21)), change in CRT (-143 [-184; -47] vs. -89 [-123; -41.5] µm [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study. TRIAL REGISTRATION: The clinical trial was registered in ClinicalTrials.gov Identifier NCT02495181 and the European Union Drug Regulating Authorities Clinical Trials Database EudraCT No. 2015-001368-20.

Late retinal and optic nerve vascular complications due to COVID-19 in young individuals.

PURPOSE: This study aims to describe the late retinal and optic nerve vascular complications due Coronavirus disease 2019 (COVID-19) in a Spanish young population. METHODS: We describe 15 eyes of 15 young patients without any other systemic risk factors, except controlled arterial hypertension in 5 of them, with the diagnosis of Central retinal vein occlusion (CRVO), Branch retinal vein occlusion (BRVO), Central retinal artery occlusion (CRAO), Branch retinal artery occlusion (BRAO), Mixed occlusions (Artery and Vein) and Non-arteritic ischemic optic neuropathy (NAION) with a previous COVID-19 infection demonstrated with a positive COVID-19 IgG Test (COVID-19 IgG/IgM Rapid Test Cassette, Lambra Laboratories, Madrid, Spain. RESULTS: 9 males and 6 females, with a mean age of presentation of 49.7 ± 9 years old were included. The mean time between infection and diagnosis of the disease was 3.5 ± 1.2 months. The most common retinal or optic nerve vascular complication was CRVO (6 cases), following by CRAO (4 cases), Mixed arterial and venous occlusions (2 cases), NAION (2 cases) and BRAO (1 case). CONCLUSIONS: The presence of a retinal or optic nerve vascular event in a young patient without any other hypercoagulable or genetic thrombophilic disorder, should make us rule out a previous COVID-19 infection. Ophthalmologists must be awared that retinal circulation could be another potential site for thromboembolic and optic nerve circulatory insufficiency complications of COVID-19. To our knowledge, this is the longest case series of retinal or optic nerve vascular events described after COVID-19 infection.

Plasma Rich in Growth Factors in Macular Hole Surgery.

The aim of this study was to evaluate the use of PRGF (plasma rich in growth factors) as an adjuvant to PPV (pars plana vitrectomy) in recurrent, persistent, or poor prognosis MH (macular hole). Patients with MH were treated with PPV plus adjuvant therapy (PRGF membrane (mPRGF) and injectable liquid PRGF (iPRGF)). The anatomical closure of MH and postoperative BCVA (best-corrected visual acuity) were evaluated. Eight eyes (eight patients) were evaluated: myopic MH (MMH, n = 4), idiopathic MH (IMH, n = 2), iatrogenic n = 1, traumatic n = 1. The mean age was 53.1 ± 19.3 years. Hence, 66.7% (n = 4) of patients previously had internal limiting membrane peeling. Five patients (62.5%) received mPRGF and iPRGF, and three patients (37.5%) received iPRGF. Gas tamponade (C3F8) was placed in seven cases and one case of silicone oil. Anatomic closure of MH was achieved in seven eyes (87.5%) and BCVA improved in six cases. In the MMH group, visual acuity improved in two lines of vision. Follow-up time was 27.2 ± 9.0 months. No adverse events or MH recurrences were recorded during follow-up. The use of PRGF as an adjuvant therapy to PPV can be useful to improve anatomical closure and visual acuity in MH surgery.

Treatment of recurrent myopic macular hole using membrane of plasma rich in growth factors.

PURPOSE: To describe the case of a patient with a recurrent large myopic macular hole (MH), who was successfully treated with a plasma rich in growth factors (PRGF) membrane. CASE REPORT: A 71-year-old patient presented a myopic MH in his right eye. One month later, pars plana vitrectomy with internal limiting membrane (ILM) peeling was performed, achieving closure of the MH. Three months later a recurrence was observed (700 µm) without visual acuity (VA) improvement. A new surgery was carried out placing an autologous PRGF-membrane into the MH, and performing a fluid-gas exchange at the end of the surgery. After two months of follow-up, the MH was completely closed, obtaining the anatomic recovery of the foveal depression, and improving the VA to 0.1. No adverse reactions were associated with the use of PRGF and there were no new recurrences of the MH in a follow-up period of six months. CONCLUSION: The use of PRGF-membrane can be used as adjunctive therapy in the surgical repair of recurrent large myopic MHs, thus improving anatomic and visual outcomes.

A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS).

PURPOSE: Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings. METHODS: POLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency. RESULTS: Outcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3-5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) µm, and the mean change in CRT was -115.2 µm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters). CONCLUSION: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.

Serous Retinal Detachment Associated with Dome-Shaped Macula and Staphyloma Edge in Myopic Patients before and after Treatment with Spironolactone.

Objective. Serous retinal detachment (SRD) is a common anatomical complication associated with dome-shaped macula (DSM) and staphyloma margin in myopic patients. Here we described the anatomical and functional outcomes obtained with the use of oral spironolactone, a mineralocorticoid antagonist, in the management of myopic patients with SRD associated with DSM and staphyloma margin. Methods. We evaluated both eyes of twelve myopic patients with long-standing SRD associated with DSM or staphyloma margin. The patients were treated daily for six months with oral spironolactone 50 mg. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT), determined by optical coherence tomography, were evaluated on the first day and on monthly follow-up visits. Results. Pretreatment BCVA (mean ± standard deviation) was 0.406 ± 0.324 LogMAR, and posttreatment BCVA was 0.421 ± 0.354 LogMAR (P = 0.489). Pretreatment CRT was 323.9 ± 78.6 µm, and after six months of treatment it was significantly lower, 291.2 ± 74.5 µm (P = 0.010). There were no treatment-related complications. Conclusions. We evaluated a novel treatment for SRD associated with DSM and staphyloma margin in myopic patients. After six months of treatment with the mineralocorticoid antagonist spironolactone, the subretinal fluid and CRT were significantly reduced; however, there was no improvement in BCVA.

Presumed latent ocular tuberculosis diagnosed with the positive quantiFERON-TB Gold In-Tube Test in a HLA-A29-positive patient.

A 59-year-old Hispanic woman presented with a 3-year history of floaters associated with bilateral reduced visual acuity. Her best-corrected visual acuity (BCVA) was 20/40. Both anterior segments were without inflammation, but fundoscopy showed mild vitreous inflammation and multiple inflammatory choroidal lesions. Tests for inflammatory and infectious diseases were negative except for human leucocyte antigen A29. The patient was diagnosed with birdshot choroidoretinopathy, and treatment was initiated with cyclosporine A 2.5 mg/kg/day. One year after treatment, the patient reported systemic symptoms with no improvement in visual acuity. Fundus findings remained with vitreal inflammation. QuantiFERON-TB Gold In-Tube Test was positive, and a diagnosis of presumed latent ocular tuberculosis (TB) was made. We initiated anti-TB treatment for 9 months. At 6 months of anti-TB therapy, there was no active inflammation. The patient was followed for 2 years with no medications and no active inflammation. Her final BCVA was 20/25.