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

NCT06694272 | Recruiting

• 1 other identifier: SBN_2024_7
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Year 4

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with early or intermediate AMD (normal visual acuity)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Amelie Yavchitz

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: April 9, 2025
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

FR (1)