Age-Related Macular DegenerationImaging4iAMDNCT06355830
Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
An observational study of Age-Related Macular Degeneration, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD. Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC. Primary outcome: Identifying imaging predictors of iAMD progression. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Orthoptic assessment (Outcome measure)
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2019to Jun 2026
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects over 55 years old with drusen secondary to intermediate AMD
Who may be able to join
- To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered.
- Accept and sign the consent.
Who cannot join
- Patients are excluded if it is not possible to obtain good quality CFP, SD-OCT, OCT-A images, if refractive error is ≥±6D or if there is any evidence of accumulation of extracellular fluid, haemorrhage, exudates or fibrosis.
- Additional exclusion criteria included any history of retinal surgery including laser treatment, signs of diabetic retinopathy, history of retinal vascular occlusion, history of anti-VEGF treatment in the study eye or any signs or history of hereditary retinal or macular dystrophy.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE
Lisbon, 1150-199
Rita Flores, MD, 00351218841000 ext. 21355, ritamariaflores@gmail.com
About this study
Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.
Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.
Primary outcome: Identifying imaging predictors of iAMD progression.
Read the detailed description
Individuals will be included consecutively and undergo retinal imaging including Color Fundus photography (CFP), Spectral Domain Optical Coherence Tomography (SD-OCT), OCT-Angiography (OCT-A) using Spectralis OCT, with OCT Angiography Module (Heidelberg Eng. GmbH, Germany), in order to characterize:
- FUNDUS AUTOFLUORESCENCE
- Analyse the correlation between drusen morphology and autofluorescent findings
- Analyse the correlation between outer retinal layers morphology and autofluorescent findings
- Assess anatomic biomarkers of disease progression
- VASCULAR FINDINGS
- Test if choriocapillaris perfusion is disturbed in Intermediate AMD patients;
- Test if retinal capillary plexus perfusion is disturbed in Intermediate AMD patients: 2.1. Analyze superficial retinal capillary plexus (SCP), 2.2. Analyze deep retinal capillary plexus (DCP);
- Assess if choroidal and retinal vascular changes are related to disease progression.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Orthoptic assessment (Outcome measure)
- Keywords
- Intermediate AMD, Progression Biomarkers, Late AMD, SD-OCT
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthoptic assessment (Outcome measure)Diagnostic test
The protocol image assessment is non-invasive and includes retinal imaging by Color Fundus photography (CFP), Spectral Domain Optical Coherence Tomography (SD-OCT), OCT-Angiography (OCT-A) using Spectralis OCT, with OCT Angiography Module (Heidelberg Eng. GmbH, Germany).
| Study group | Role | What they receive |
|---|---|---|
| intermediate AMD | Subjects over 55 years old with drusen secondary to intermediate AMD Receives: Diagnostic Test: Orthoptic assessment (Outcome measure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
iRORA is measured in μm
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen morphology from baseline
Drusen classified as Serous, Reticular or both
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Subfoveal drusen area from baseline
Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in other drusen area from baseline
Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen reflectivity from baseline
Drusen reflectivity classified as a) Low, b) Intermediate, c) High
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in other Drusen homogeneity from baseline
Drusen homogeneity classified in a) Low b) Intermediate or c) High
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in ellipsoid zone disruption from baseline
ellipsoid zone disruption changes classified in a) Yes or b) No
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen homogeneity from baseline
Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci from baseline
Hyperreflective foci changes classified in a) Yes or b) No
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci location (within 500-μm disc area) from baseline
hyperreflective foci location (within 500-μm disc area) changes classified as a) Yes or b) No
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci association to drusen from baseline
hyperreflective foci association to drusen from baseline classified as a) Yes or b) No
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression to Moderate Vision Loss
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Geographic Atrophy (GA) Growth Rate
The annual growth rate of GA or nascent GA area measured in square root transform of the area measured in mm2 (final values in mm), based on SD-OCT Spectralis Heidelberg
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Secondary outcomes (1)
Progression to Advanced AMD according to international classification/grading system
Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules.
Measured: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 Jan 2019
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL, Centro Hospitalar de Lisboa Central, Centro Hospitalar De São João, E.P.E.
- Responsible party
- Sponsor
- Investigators
- Rita Flores, MD, Principal investigator, Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de LisboaSandra Tenreiro, PhD, Study chair, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355830
- Sponsor's protocol ID
- RETimaging4iAMD
- Acronym
- Imaging4iAMD
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
- ClinicalTrials.gov ID
- NCT06355830
- Acronym / sponsor ID
- Imaging4iAMD / RETimaging4iAMD
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Intermediate AMD, Progression Biomarkers, Late AMD, SD-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL, Centro Hospitalar de Lisboa Central, Centro Hospitalar De São João, E.P.E.
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Apr 2024 (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.
Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.
Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.
Primary outcome: Identifying imaging predictors of iAMD progression.
Detailed description
Individuals will be included consecutively and undergo retinal imaging including Color Fundus photography (CFP), Spectral Domain Optical Coherence Tomography (SD-OCT), OCT-Angiography (OCT-A) using Spectralis OCT, with OCT Angiography Module (Heidelberg Eng. GmbH, Germany), in order to characterize:
- FUNDUS AUTOFLUORESCENCE
- Analyse the correlation between drusen morphology and autofluorescent findings
- Analyse the correlation between outer retinal layers morphology and autofluorescent findings
- Assess anatomic biomarkers of disease progression
- VASCULAR FINDINGS
- Test if choriocapillaris perfusion is disturbed in Intermediate AMD patients;
- Test if retinal capillary plexus perfusion is disturbed in Intermediate AMD patients: 2.1. Analyze superficial retinal capillary plexus (SCP), 2.2. Analyze deep retinal capillary plexus (DCP);
- Assess if choroidal and retinal vascular changes are related to disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intermediate AMD | – | Diagnostic Test: Orthoptic assessment (Outcome measure)Subjects over 55 years old with drusen secondary to intermediate AMD |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 55 years old with drusen secondary to intermediate AMD
Key inclusion criteria (2 listed)
- To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered.
- Accept and sign the consent.
Key exclusion criteria (2 listed)
- Patients are excluded if it is not possible to obtain good quality CFP, SD-OCT, OCT-A images, if refractive error is ≥±6D or if there is any evidence of accumulation of extracellular fluid, haemorrhage, exudates or fibrosis.
- Additional exclusion criteria included any history of retinal surgery including laser treatment, signs of diabetic retinopathy, history of retinal vascular occlusion, history of anti-VEGF treatment in the study eye or any signs or history of hereditary retinal or macular dystrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthoptic assessment (Outcome measure)The protocol image assessment is non-invasive and includes retinal imaging by Color Fundus photography (CFP), Spectral Domain Optical Coherence Tomography (SD-OCT), OCT-Angiography (OCT-A) using Spectralis OCT, with OCT Angiography Module (Heidelberg Eng. GmbH, Germany). | Diagnostic test | intermediate AMD |
Primary outcome
Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
iRORA is measured in μm
Change in Drusen morphology from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen classified as Serous, Reticular or both
Change in Subfoveal drusen area from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in other drusen area from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in Drusen reflectivity from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen reflectivity classified as a) Low, b) Intermediate, c) High
Change in other Drusen homogeneity from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified in a) Low b) Intermediate or c) High
Change in ellipsoid zone disruption from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
ellipsoid zone disruption changes classified in a) Yes or b) No
Change in Drusen homogeneity from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous
Change in hyperreflective foci from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Hyperreflective foci changes classified in a) Yes or b) No
Change in hyperreflective foci location (within 500-μm disc area) from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci location (within 500-μm disc area) changes classified as a) Yes or b) No
Change in hyperreflective foci association to drusen from baseline
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci association to drusen from baseline classified as a) Yes or b) No
Progression to Moderate Vision Loss
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Geographic Atrophy (GA) Growth Rate
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
The annual growth rate of GA or nascent GA area measured in square root transform of the area measured in mm2 (final values in mm), based on SD-OCT Spectralis Heidelberg
1 secondary outcome
Progression to Advanced AMD according to international classification/grading system
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rita Flores, MD principal investigator
Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
Sandra Tenreiro, PhD study chair
iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
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 Universidade Nova de Lisboa at 1 site in Portugal.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rita Flores, MD (00351218841000 ext. 21355, ritamariaflores@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline (time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48). The study lists 13 primary outcomes in all. 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 9 Apr 2024.