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Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study

ConditionAge-Related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-95
SponsorUniversidade Nova de Lisboa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Accept and sign the consent.

Disqualifiers

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 population

Subjects over 55 years old with drusen secondary to intermediate AMD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: intermediate AMD1 intervention

Trial outcomes

Primary outcomes

1

Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline

iRORA is measured in μm

Time frame
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
2

Change in Drusen morphology from baseline

Drusen classified as Serous, Reticular or both

Time frame
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
3

Change in Subfoveal drusen area from baseline

Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg

Time frame
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
4

Change in other drusen area from baseline

Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg

Time frame
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.

Time frame
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL

Collaborator

Centro Hospitalar de Lisboa Central

Collaborator

Centro Hospitalar De São João, E.P.E.

Collaborator

Source ClinicalTrials.gov
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