Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME

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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Grupo de Estudos da RetinaUpdated: Aug 12, 2026
Eligibility criteria

Diagnosis of neovascular age-related macular degeneration in the eye under treat... [+9]

Concurrent participation in an interventional clinical investigation involving p... [+11]