Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration (NOGA1)

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.

Study Overview

• Status: Recruiting
• Conditions: Age Related Macular Degeneration

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Amelie Yavchitz; Phone Number: +33148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
    • Contact: Sophie Bonnin; Phone Number: +33 (0)148036437; Email: sbonnin@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

subjects with early or intermediate AMD (normal visual acuity)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: SBN_2024_7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No