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

NCT ID: NCT06694272

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-09
• Study Completion Date: 2031-04-30

Brief Summary

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.

Conditions

Age Related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

subjects with early or intermediate AMD (normal visual acuity)

At inclusion patients will have :

• Measurements of subjective refraction, visual acuity, intraocular pressure, slit-lamp examination
• Measurement of low-luminance visual acuity
• Measurement of low-light contrast sensitivity
• Photometric (> 30 cd/m² > 10 min) and scotopic (DA > 20 min) microperimetry
• Multifocal electroretinogram
• Imaging using fundus photography, OCT, OCT-A, adaptive optics and autofluorescence
• Venous blood sampling (48 mL)

After 4 years of follow-up, AMD evolution will be assessed with :

• Measurements of subjective refraction, visual acuity, intraocular pressure, slit-lamp examination
• Imaging by fundus photography, OCT, OCT-A, and autofluorescence

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient over 18 years of age
• Corrected visual acuity 10/10 in each eye
• Presence of retinal alteration(s) compatible with early (presence of macular drusen < 125 μm) or intermediate (macular drusen > 125 μm or pigmentary abnormalities) AMD in at least one of the two eyes :

• Conventional "soft" or "hard" drusen
• Cuticular drusen
• Reticulated pseudo-drusen

Exclusion Criteria

• 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
• Neurological/neurodegenerative pathology that may prevent adequate performance of functional tests: advanced Parkinsonian syndromes, Benson's disease, Alzheimer's disease with visuomotor apraxia
• Other ophthalmological pathology that may affect anatomical and functional measurements: hypertonia / glaucoma or other optic neuropathy, media disorder causing reduced visual acuity, refraction < -6.00D or > +6.00D
• Other medical conditions preventing examinations or imaging (tremors, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Fondation A. de Rothschild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amelie Yavchitz

Role: CONTACT

ayavchitz@for.paris

+33148036454

Facility Contacts

Sophie Bonnin

Role: primary

sbonnin@for.paris

(0)148036437 ext. +33

Other Identifiers

SBN_2024_7

Identifier Type: -

Identifier Source: org_study_id