Age-Related Macular DegenerationVERA-AMDNCT06899360
Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration.
An observational study of Age-Related Macular Degeneration, run by University of Udine at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by age-related macular degeneration
Who may be able to join
- age ≥ 50 years.
- confirmed diagnosis of AMD in at least one eye.
- follow-up scheduled according to standard clinical practice.
Who cannot join
- presence of other significant ocular conditions that could affect visual acuity.
- systemic conditions that make the patient unsuitable for long-term follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Ophthalmology
Udine, UD, 33100
Daniele Veritti, +390432559907, daniele.veritti@uniud.it
About this study
Official title: Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration (VERA-nAMD).
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.
Read the detailed description
The VERA-AMD study is a prospective, non-interventional, observational study investigating the clinical course, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). AMD is a leading cause of vision loss among the elderly, manifesting as either neovascular ("wet") AMD (nAMD) or geographic atrophy ("dry") AMD (GA-AMD). Despite advances in treatment, there is considerable variability in disease progression and response to therapy. This study aims to fill this gap by analyzing real-world data to identify predictors of disease progression and functional outcomes, ultimately improving clinical management strategies.
Study Objectives
The study's main objectives are to:
Assess the clinical progression of AMD in routine clinical practice. Identify prognostic factors associated with favorable or unfavorable disease outcomes.
Evaluate the impact of AMD on patient quality of life using validated questionnaires.
Methodology
Design: Prospective, non-profit, observational study. Population: 200 patients aged ≥50 years with confirmed AMD in at least one eye. Inclusion Criteria: Confirmed diagnosis of AMD, scheduled follow-up according to clinical practice.
Exclusion Criteria: Significant ocular or systemic diseases affecting visual outcomes.
Outcomes
Primary Outcome: Progression rate to advanced AMD, expressed as cases per 100 patient-years.
Secondary Outcomes: Changes in visual acuity, retinal morphology assessed by optical coherence tomography (OCT), and patient-reported quality of life.
Anti-VEGF Therapy and AI-Based Fluid Analysis
A significant part of the study focuses on the role of anti-VEGF treatment in controlling disease progression, especially in nAMD. Anti-VEGF agents such as aflibercept and ranibizumab are standard treatments for neovascular AMD, aiming to reduce fluid accumulation and neovascularization. The study will explore the relationship between treatment regimens (fixed vs. as-needed dosing) and clinical outcomes, including visual acuity and anatomical changes.
Artificial intelligence (AI)-based analysis of retinal fluid dynamics will be employed using OCT imaging data. Machine learning algorithms will be applied to identify patterns in fluid accumulation and disease progression, improving early detection and personalized treatment approaches.
Data Collection and Statistical Analysis
Data will be collected through regular clinical visits, OCT imaging, and visual acuity testing. Statistical analysis will include repeated measures models to evaluate disease progression and predictors of clinical outcomes. Sample size calculations anticipate a 5.2% annual progression rate in early/intermediate AMD and a 19.7% rate in advanced AMD, with an 80% statistical power at a 0.05 significance level.
Timeline
Interim analysis after 12 months (50 patients with follow-up). Primary analysis after 12 months (all patients). Follow-up analysis at 36 months. Consent and Ethics
Informed consent will be obtained from all participants. Data will be anonymized and handled according to ethical guidelines and institutional review board (IRB) protocols.
- Conditions
- Age-Related Macular Degeneration
- Keywords
- age-related macular degeneration, artificial intelligence, anti-VEGF
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
visual acuity measured as ETDRS letters
Measured: through study completion, 36 months
Secondary outcomes (3)
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]
Measured: through study completion, 36 months
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
Measured: through study completion, 36 months
central retinal thickness
central retinal thickness
Measured: through study completion, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Veritti, University of Udine
- Investigators
- Daniele Veritti, Principal investigator, Department of Ophthalmology, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899360
- Sponsor's protocol ID
- OCU_DMED_2025_1
- Acronym
- VERA-AMD
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration (VERA-nAMD).
- ClinicalTrials.gov ID
- NCT06899360
- Acronym / sponsor ID
- VERA-AMD / OCU_DMED_2025_1
- Conditions
- Age-Related Macular Degeneration
- Keywords
- age-related macular degeneration, artificial intelligence, anti-VEGF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The VERA-AMD study is a prospective, non-interventional, observational study investigating the clinical course, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). AMD is a leading cause of vision loss among the elderly, manifesting as either neovascular ("wet") AMD (nAMD) or geographic atrophy ("dry") AMD (GA-AMD). Despite advances in treatment, there is considerable variability in disease progression and response to therapy. This study aims to fill this gap by analyzing real-world data to identify predictors of disease progression and functional outcomes, ultimately improving clinical management strategies.
Study Objectives
The study's main objectives are to:
Assess the clinical progression of AMD in routine clinical practice. Identify prognostic factors associated with favorable or unfavorable disease outcomes.
Evaluate the impact of AMD on patient quality of life using validated questionnaires.
Methodology
Design: Prospective, non-profit, observational study. Population: 200 patients aged ≥50 years with confirmed AMD in at least one eye. Inclusion Criteria: Confirmed diagnosis of AMD, scheduled follow-up according to clinical practice.
Exclusion Criteria: Significant ocular or systemic diseases affecting visual outcomes.
Outcomes
Primary Outcome: Progression rate to advanced AMD, expressed as cases per 100 patient-years.
Secondary Outcomes: Changes in visual acuity, retinal morphology assessed by optical coherence tomography (OCT), and patient-reported quality of life.
Anti-VEGF Therapy and AI-Based Fluid Analysis
A significant part of the study focuses on the role of anti-VEGF treatment in controlling disease progression, especially in nAMD. Anti-VEGF agents such as aflibercept and ranibizumab are standard treatments for neovascular AMD, aiming to reduce fluid accumulation and neovascularization. The study will explore the relationship between treatment regimens (fixed vs. as-needed dosing) and clinical outcomes, including visual acuity and anatomical changes.
Artificial intelligence (AI)-based analysis of retinal fluid dynamics will be employed using OCT imaging data. Machine learning algorithms will be applied to identify patterns in fluid accumulation and disease progression, improving early detection and personalized treatment approaches.
Data Collection and Statistical Analysis
Data will be collected through regular clinical visits, OCT imaging, and visual acuity testing. Statistical analysis will include repeated measures models to evaluate disease progression and predictors of clinical outcomes. Sample size calculations anticipate a 5.2% annual progression rate in early/intermediate AMD and a 19.7% rate in advanced AMD, with an 80% statistical power at a 0.05 significance level.
Timeline
Interim analysis after 12 months (50 patients with follow-up). Primary analysis after 12 months (all patients). Follow-up analysis at 36 months. Consent and Ethics
Informed consent will be obtained from all participants. Data will be anonymized and handled according to ethical guidelines and institutional review board (IRB) protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by age-related macular degeneration
Key inclusion criteria (3 listed)
- age ≥ 50 years.
- confirmed diagnosis of AMD in at least one eye.
- follow-up scheduled according to standard clinical practice.
Key exclusion criteria (2 listed)
- presence of other significant ocular conditions that could affect visual acuity.
- systemic conditions that make the patient unsuitable for long-term follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: through study completion, 36 months
visual acuity measured as ETDRS letters
3 secondary outcomes
Self-reported vision-targeted quality of life
Time frame: through study completion, 36 months
Fluid volume (nL) in the retinal compartments
Time frame: through study completion, 36 months
central retinal thickness
Time frame: through study completion, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniele Veritti principal investigator
Department of Ophthalmology, University of Udine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by University of Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Veritti (+390432559907, daniele.veritti@uniud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) (time frame: through study completion, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.