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

NCT06899360 | Recruiting

• 1 other identifier: OCU_DMED_2025_1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration

Keywords

age-related macular degeneration; artificial intelligence; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity (BCVA)

  visual acuity measured as ETDRS letters

  through study completion, 36 months

Secondary Outcomes (3)

• Self-reported vision-targeted quality of life

  through study completion, 36 months

• Fluid volume (nL) in the retinal compartments

  through study completion, 36 months

• central retinal thickness

  through study completion, 36 months

Study Arms (1)

Observational cohort of patients with age-related macular degeneration

Observational cohort of patients with age-related macular degeneration eventually receiving anti-VEGF agents as per clinical practice.

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by age-related macular degeneration

You may qualify if:

• age ≥ 50 years.
• confirmed diagnosis of AMD in at least one eye.
• follow-up scheduled according to standard clinical practice.

You may not qualify if:

• presence of other significant ocular conditions that could affect visual acuity.
• systemic conditions that make the patient unsuitable for long-term follow-up.

Sponsors & Collaborators

• University of Udine: lead

Study Sites (1)

Department of Ophthalmology

Udine, UD, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Daniele Veritti

  Department of Ophthalmology, University of Udine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Veritti

CONTACT

+390432559907; daniele.veritti@uniud.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 27, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

IT (1)