Informations générales (source: ClinicalTrials.gov)

NCT06694272 En recrutement IDF
Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration (NOGA1)
Observational
  • Dégénérescence maculaire
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
avril 2025
avril 2031
30 avril 2025
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Sophie Bonnin En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
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



- 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.)