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Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME
Sponsor: Grupo de Estudos da Retina
Summary
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.
Official title: Multicentre Observational Study to Investigate 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-09-01
Completion Date
2027-12-31
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
Aflibercept 8mg
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.