About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of neovascular age-related macular degeneration in the eye under treatment.
Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.
The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.
The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.
Disqualifiers
Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.
Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.
Active extra-ocular or peri-ocular infection or active intraocular inflammation in either eye at the time of the first switch-related aflibercept 8 mg injection.
Pre-existing ophthalmological condition in the eye under treatment (other than nAMD or DME) that, in the investigator's judgment, could materially affect the assessment of study outcomes - for example, advanced uncontrolled glaucoma, optic neuropathy or other retinal pathology.
Trial population
The study population comprises adult patients receiving routine ophthalmic care at participating centres in Portugal who have neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME), have previously received intravitreal therapy, and are switched to intravitreal aflibercept 8 mg according to the treating physician's clinical judgment and routine practice. Eligible eyes are enrolled consecutively from participating sites and followed using data collected during routine clinical care.
Trial design
Cohort
Other
Treatments tested in this trial
Aflibercept 8mg
DrugIntravitreal 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Change in BCVA
Proportion of eyes achieving gains or losses of ≥5, ≥10, and ≥15 ETDRS letters from baseline.
Change in Central Retinal Thickness (CRT)
Change from baseline in central retinal thickness measured by optical coherence tomography (OCT).
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.
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