Clinical trial NCT06355830: Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
Official title: Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age-Related Macular Degeneration
Keywords: Intermediate AMD
Progression Biomarkers
Late AMD
SD-OCT
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL
name: Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal
name: Centro Hospitalar De São João, E.P.E.
First posted: 2024-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over 55 years old with drusen secondary to intermediate AMD

Brief 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.

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:

A. FUNDUS AUTOFLUORESCENCE

1. Analyse the correlation between drusen morphology and autofluorescent findings
2. Analyse the correlation between outer retinal layers morphology and autofluorescent findings
3. Assess anatomic biomarkers of disease progression

B. VASCULAR FINDINGS

1. Test if choriocapillaris perfusion is disturbed in Intermediate AMD patients;
2. 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);
3. Assess if choroidal and retinal vascular changes are related to disease progression.

Eligibility criteria: Inclusion Criteria:

* To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered.
* Accept and sign the consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in Drusen morphology from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in Subfoveal drusen area from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in other drusen area from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in Drusen reflectivity from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in other Drusen homogeneity from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in ellipsoid zone disruption from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in Drusen homogeneity from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in hyperreflective foci from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in hyperreflective foci location (within 500-μm disc area) from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Change in hyperreflective foci association to drusen from baseline
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Progression to Moderate Vision Loss
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
measure: Geographic Atrophy (GA) Growth Rate
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Secondary outcomes:
measure: Progression to Advanced AMD according to international classification/grading system
timeFrame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE
Study officials:
affiliation: Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
name: Rita Flores, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
name: Sandra Tenreiro, PhD
role: STUDY_CHAIR
References: