Clinical Trial

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

Study acronym: ALLEVI8
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07761039
Lead Sponsor Grupo de Estudos da Retina
Conditions nAMD, DME
Enrollment 100 participants
Start Date 2026-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12