Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

Age-related macular degeneration (AMD) is the leading cause of visual impairment in industrialized countries. Anatomical examination findings at the early and intermediate stages of AMD are not sufficient to determine any functional alterations at these stages (e.g., alterations in microperimetry, multifocal electroretinogram (mfERG) and contrast sensitivity). Identifying early functional markers of the disease is a necessary first step in the development and clinical validation of treatments to slow progression to advanced disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years of age

Corrected visual acuity 10/10 in each eye

Conventional "soft" or "hard" drusen

Cuticular drusen

Disqualifiers

Presence of geographic atrophy, even incipient, in one or both eyes

Presence of patent or latent neovascularization visible on OCT b-scan or OCT-A in one or both eyes

Compatibility of retinal signs with a "probable" differential diagnosis (bestrophinopathies, familial drusen, fundus flavimaculatus, fundus albipunctatus, hypovitaminosis A) in one or both eyes.

Oculomotor pathology that may prevent proper performance of functional tests: nystagmus, oculomotor paralysis, in one or both eyes

Trial population

subjects with early or intermediate AMD (normal visual acuity)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: subjects with early or intermediate AMD (normal visual acuity)

Trial outcomes

Primary outcomes

1

AMD evolution at 4 years

AMD is considered to have progressed if, after 4 years, the patient has developed an advanced form of the disease. The onset of an advanced form is defined by the appearance of macular neovascularization (of any type), visible on fundus or OCT/OCT-A, or by the appearance of macular atrophy visible on fundus, autofluorescence or OCT.

Time frame
Year 4

Secondary outcomes

Other outcomes

Sponsors and contacts

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