The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal. It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice. The main questions it aims to answer are: \- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice? Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.
Study Type
OBSERVATIONAL
Enrollment
100
Intravitreal aflibercept 8 mg administered as part of routine clinical practice according to the locally approved prescribing information. Treatment initiation, dosing regimen, injection intervals, and treatment duration are determined by the treating physician independently of study participation. No study-specific treatment procedures or interventions are mandated by the protocol.
Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg
The last achieved treatment interval (days) following initiation of intravitreal aflibercept 8 mg, defined as the interval between the two most recent consecutive aflibercept 8 mg injections documented within each analysis window. The endpoint is summarized descriptively to evaluate the interval-extension potential under routine clinical practice.
Time frame: Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA from baseline, measured in ETDRS letters, following initiation of intravitreal aflibercept 8 mg under routine clinical practice
Time frame: Baseline, Months 6, 12, and 24 (if available)
Change in BCVA
Proportion of eyes achieving gains or losses of ≥5, ≥10, and ≥15 ETDRS letters from baseline.
Time frame: Months 6, 12, and 24
Change in Central Retinal Thickness (CRT)
Change from baseline in central retinal thickness measured by optical coherence tomography (OCT).
Time frame: Baseline, Months 6, 12, and 24
Retinal Fluid Status
Presence or absence of intraretinal fluid (IRF), subretinal fluid (SRF), and, where applicable, sub-retinal pigment epithelium (sub-RPE) fluid on OCT during follow-up.
Time frame: Months 6, 12, and 24 (if available)
Number of Intravitreal Aflibercept 8 mg Injections
Number of intravitreal aflibercept 8 mg injections administered during follow-up as part of routine clinical practice.
Time frame: Up to 24 months
Ocular and Systemic Safety
Incidence of ocular and systemic adverse events and serious adverse events reported during treatment with intravitreal aflibercept 8 mg under routine clinical practice.
Time frame: From baseline to Month 24
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