Sérgio Leal
A5022217015- Retinal Diseases and Treatments
- Retinal Imaging and Analysis
- Retinal and Optic Conditions
- Glaucoma and retinal disorders
- Ocular Diseases and Behçet’s Syndrome
- Ophthalmology and Visual Impairment Studies
- Retinopathy of Prematurity Studies
- Retinal and Macular Surgery
- Health Systems, Economic Evaluations, Quality of Life
- Antioxidant Activity and Oxidative Stress
- Neonatal Respiratory Health Research
- Nerve Injury and Rehabilitation
- Corneal surgery and disorders
- Network Security and Intrusion Detection
- Software Testing and Debugging Techniques
- Healthcare Systems and Reforms
- Shoulder Injury and Treatment
- Cardiovascular Conditions and Treatments
- Corneal Surgery and Treatments
- Urban Green Space and Health
- Advanced Malware Detection Techniques
- Economic and Environmental Valuation
- Shoulder and Clavicle Injuries
- Ethics in Clinical Research
Bayer (Switzerland)
2018-2025
Regeneron (United States)
2025
University of Sheffield
2024
University of Bonn
2024
Bayer (Germany)
2017-2023
Association for Innovation and Biomedical Research on Light and Image
2010-2014
University of Coimbra
2010
Baylor College of Medicine
2005
Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed.To evaluate intravitreal aflibercept injection (IAI) participants with PCV and compare IAI monotherapy plus rescue photodynamic therapy (PDT).This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, Taiwan from May 2014 August 2016,...
Introduction: There is an unmet medical need for therapies in intermediate age-related macular degeneration (iAMD). The prospective European multi-center cohort study MACUSTAR validates structural, functional and patient-reported iAMD endpoints use future trials. multiplicity of assessments allows characterizing more dimensions than previously available. We describe the heterogeneity baseline study. Methods: A wide range were administered across 20 sites accordance with established...
Importance Prospective long-term data after retinopathy of prematurity (ROP) treatment with anti–vascular endothelial growth factor injections vs laser therapy are scarce. The FIREFLEYE (Aflibercept for ROP IVT Injection Laser Therapy) next trial is prospectively evaluating the efficacy and safety outcomes following intravitreal aflibercept therapy. Objective To evaluate 2-year ophthalmic 0.4-mg injection or in 24-week randomized (2:1) (FIREFLEYE previously reported). Design, Setting,...
Purpose: The purpose of this study was to compare intravitreal nesvacumab (anti-angiopoietin 2) plus aflibercept with injection (IAI) in diabetic macular edema. Methods: eyes (n = 302) were randomized (1:2:3) 3 mg + 2 (LD combo), 6 (HD or IAI at baseline, Weeks 4 and 8. LD combo continued every 8 weeks (q8w). HD rerandomized Week 12 q8w (q12w); q8w, q12w, through 32. Results: best-corrected visual acuity gains for versus 6.8, 8.5, 8.8 letters; 36 changes similar. Central subfield retinal...
To report the prevalence and topographic distribution of structural characteristics in study participants with age-related macular degeneration (AMD) controls cross-sectional part MACUSTAR (ClinicalTrials.gov Identifier: NCT03349801).European, multicenter cohort study.Overall, 301 eyes subjects early (n = 34), intermediate 168), late AMD 43), as well without any features 56).In (iAMD), presence biomarkers, including pigmentary abnormalities (PAs), pigment epithelium detachment (PED),...
In Brief Purpose: The purpose of this study was to evaluate the efficacy verteporfin photodynamic therapy on treatment polypoidal choroidal vasculopathy. Methods: A prospective, nonrandomized institutional conducted involving 42 eyes 38 patients with newly diagnosed symptomatic vasculopathy treated exclusively therapy. Twenty-seven completed 3 years follow-up. Subjects were observed every months evaluation best-corrected visual acuity (BCVA), retinography, and fluorescein indocyanine green...
Abstract Background There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, any new interventions to be tested clinical trials, novel currently unavailable endpoints developed. Thus, the MACUSTAR study aims develop and evaluate functional, structural, patient-reported candidate use future iAMD trials. Methods The protocol describes a low-interventional multicenter employing two-part design. cross-sectional part (total duration, 1 month)...
Purpose: The purpose of this study was to assess test-retest variability and discriminatory power measures from macular integrity assessment (S-MAIA) AdaptDx. Methods: This is a cross-sectional 167 people with intermediate age-related degeneration (iAMD), no AMD (controls; n = 54), early (n 28), late 41), recruited across 18 European ophthalmology centers. Repeat mesopic scotopic S-MAIA average (mean) threshold (MMAT decibels [dB] SMAT [dB]) rod intercept time (RIT [mins]) at 2 visits 14...
Purpose: To determine the reported rates of intraocular inflammation (IOI) in patients treated with intravitreal aflibercept (IVT-AFL) 2 mg routine clinical practice (ie, outside interventional studies), across all indications and within countries (excluding United States), access to either vial presentation or pre-filled syringe (PFS). Patients methods: A search was conducted using Bayer EYLEA ® Global Safety Pharmacovigilance Database for cases IOI IVT-AFL use between October 2012 March...
Abstract This study aimed to determine the retest variability of quantitative fundus autofluorescence (QAF) in patients with and without age-related macular degeneration (AMD) evaluate predictive value patient reliability indices on reliability. A total 132 eyes from 68 were examined, including healthy individuals those various stages AMD. Duplicate QAF imaging was conducted at baseline 2 weeks later across six sites. Intraclass correlation (ICC) analysis used consistency imaging, mean...
There is a need for validated clinical end points that are reliably able to quantify potential therapeutic effects of future treatments targeting age-related macular degeneration (AMD) before the onset serious visual impairment.To assess reliability and discriminatory power 5 simple chart-based function (VF) tests as measures trial with regulatory patient-access intention in intermediate AMD (iAMD).This international noninterventional study took place at 18 tertiary ophthalmology departments...
Abstract Quantification of the relative ellipsoid zone reflectivity (rEZR) might be a structural surrogate parameter for an early disease progression in context age-related macular degeneration (AMD). Within European multicenter, cross-sectional MACUSTAR study, we have devised automatic approach to determine mean rEZR [arbitrary units, AU] at two independent visits SD-OCT volume scans study participants. Linear mixed-effects models were applied analyze association AMD stage and associated...
The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year treatment, in patients diabetic macular edema (DME). VIOLET a 100-week, randomized, Phase IIIb, non-inferiority study center-involving DME previously treated IVT-AFL for ≥ 1 according European label.Patients received an initial dose at baseline and were randomly assigned (1:1:1) treat-and-extend (T&E), pro re nata (PRN), or regimens. primary endpoint...
Purpose: To analyze the intersession repeatability of structural biomarkers in eyes with early and intermediate age-related macular degeneration (iAMD) within cross-sectional part observational multicenter MACUSTAR study. Methods: Certified site personnel obtained multimodal imaging data at two visits (38 ± 20 [mean standard deviation] days apart), including spectral-domain optical coherence tomography (SD-OCT). One junior reader performed systematic blinded grading central reading center,...
Abstract Drusen are hallmarks of early and intermediate age-related macular degeneration (AMD) but their quantification remains a challenge. We compared automated drusen volume measurements between different OCT devices. included 380 eyes from 200 individuals with bilateral (iAMD, n = 126), (eAMD, 25) or no AMD (n 49) the MACUSTAR study. assessed scans Cirrus (200 × cube, 6 mm; Zeiss Meditec, CA) Spectralis (20° 20°, 25 B-scans; 30° 25°, 241 Heidelberg Engineering, Germany) Sensitivity...
Neovascular glaucoma is characterized by neovascularization of the iris and anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may decrease intraocular pressure (IOP) improve neovascularization. The VENERA study assessed efficacy safety intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma. This was a 5-week, single-arm, nonrandomized, open-label, phase 3 performed at 7 sites Japan that enrolled Japanese segment IOP > 25 mmHg who had not...
To compare intravitreal nesvacumab (anti-angiopoietin-2) + aflibercept vs injection (IAI) in neovascular age-related macular degeneration (nAMD).Eyes were randomized (1:2:3) to 3 mg 2 (LD combo), 6 (HD or IAI at baseline, week 4, and 8. The LD combo was continued every 8 weeks (q8w). At 12, the HD re-randomized q8w 12 (q12w) q8w, q12w, through 32.The study comprised 365 eyes. mean best-corrected visual acuity (BCVA) gains from baseline similar group, group (5.2 letters, 5.6 5.4...