Investigating vision changes in early age-related macular degeneration
Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration
This study is trying to see how early changes in vision affect people with early age-related macular degeneration to help find better treatments in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT06694272 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with early forms of age-related macular degeneration (AMD), which is a leading cause of visual impairment. It aims to identify functional markers of the disease by examining alterations in visual function through tests like microperimetry and multifocal electroretinogram. The study will include patients with specific retinal alterations while excluding those with more advanced disease or other complicating factors. By understanding these early changes, the research seeks to pave the way for future treatments to slow disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with early or intermediate AMD and good corrected visual acuity.
Not a fit: Patients with advanced AMD or other significant ocular or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and intervention strategies for patients with age-related macular degeneration.
How similar studies have performed: While there have been studies on AMD, this specific approach to identifying early functional markers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Paris
- Hôpital Fondation A. de Rothschild — Paris, France (Recruiting)
Study contacts
- Study coordinator: Amelie Yavchitz
- Email: ayavchitz@for.paris
- Phone: +33148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.