Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-120
SponsorUniversity of Udine

About this trial

The VERA-AMD study is a prospective, observational study designed to evaluate clinical progression, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). The study aims to analyze real-world clinical data to identify key predictors of disease progression and functional outcomes, with the goal of optimizing AMD management. The study involves 200 patients aged ≥50 with a confirmed diagnosis of AMD, monitored through routine clinical practice. Primary outcomes include progression rates to advanced AMD and changes in visual acuity, while secondary outcomes focus on retinal morphology and quality of life. Anti-VEGF therapy and AI-based fluid analysis will be integrated to explore their impact on disease progression and patient outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 50 years.

confirmed diagnosis of AMD in at least one eye.

follow-up scheduled according to standard clinical practice.

Disqualifiers

presence of other significant ocular conditions that could affect visual acuity.

systemic conditions that make the patient unsuitable for long-term follow-up.

Trial population

Patients affected by age-related macular degeneration

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Observational cohort of patients with age-related macular degeneration

Trial outcomes

Primary outcomes

1

Best-corrected visual acuity (BCVA)

visual acuity measured as ETDRS letters

Time frame
through study completion, 36 months

Secondary outcomes

1

Self-reported vision-targeted quality of life

Self-reported vision-targeted quality of life will be measured using National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). \[Score 0-100, higher scores mean a better outcome\]

Time frame
through study completion, 36 months
2

Fluid volume (nL) in the retinal compartments

Artificial intelligence based fluid analysis. Measurement of fluid volume (nL) in the intraretinal, subretinal and sub retinal pigment epithelium compartments

Time frame
through study completion, 36 months
3

central retinal thickness

central retinal thickness

Time frame
through study completion, 36 months

Other outcomes

Sponsors and contacts

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