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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06694272
Acronym
NOGA1
Enrollment
120
Registered
2024-11-19
Start date
2025-04-09
Completion date
2031-04-01
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

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.

Interventions

None listed

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
AMD evolution at 4 yearsYear 4AMD 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.

Countries

France

Contacts

CONTACTAmelie Yavchitz
ayavchitz@for.paris+33148036454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026