Age Related Macular DegenerationNOGA1NCT06694272
Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2025to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with early or intermediate AMD (normal visual acuity)
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Raphaël Lejoyeux, Dr, (0)148036437 ext. +33, rlejoyeux@for.paris
About this study
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.
- Conditions
- Age Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start9 Apr 2025
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694272
- Sponsor's protocol ID
- SBN_2024_7
- Acronym
- NOGA1
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06694272
- Acronym / sponsor ID
- NOGA1 / SBN_2024_7
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with early or intermediate AMD (normal visual acuity)
Key inclusion criteria (6 listed)
- 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 :
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AMD evolution at 4 years
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMD evolution at 4 years (time frame: Year 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.