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

Recruiting

• Conditions: Age Related Macular Degeneration

• Registration Number: NCT06694272
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-19
• Status Verified: 2025-04
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMD evolution at 4 years	Year 4	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.

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France