An interventional study of Autofluorescence Imaging and Infrared reflectance imaging in Normal Eyes, Age Related Macular Degeneration and Diabetic Retinopathy, sponsored by Heidelberg Engineering GmbH. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Heidelberg Engineering GmbH (part of EssilorLuxottica) · Not applicable, Interventional, and Other
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Among 97 studies in Macular Degeneration with a site in Italy — 22 open to participants now, 31 under way, 10 of them phase 3. Macular Degeneration · Italy.
Among the 97 studies in Macular Degeneration with a site in Italy, this one is the 52nd largest by planned enrollment of the 76 interventional ones that give a count, is one of 4 that started in 2026, is one of 20 with no phase, reaches primary completion later than 12 of the 30 other live ones, and was the 91st registered.
1,459 studies on the registry are indexed under Macular Degeneration; 236 are open to participants now.
Browse Macular Degeneration studies →22 of the 97 studies in Macular Degeneration with a site in Italy are open now. Recruiting first, the newest first:
EyeBiotech Ltd. · Sites in Italy, United States, Brazil and 6 more countries
Ages 50+
Novartis Pharmaceuticals · Sites in Italy, United States, Argentina and 16 more countries
Ages 50+
Hoffmann-La Roche · Sites in Italy, Austria, Czechia and 10 more countries
Ages 50+
ADARx Pharmaceuticals, Inc. · Sites in Italy, United States, Australia and 9 more countries
Ages 60+
AbbVie · Sites in Italy, United States, Austria and 14 more countries
Ages 50+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
97 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 22 · Phase 3 33 · Phase 4 5
First in 2006; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 97 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Median enrollment 272 across the 76 interventional studies, 160 across the 20 observational. Of the 60 that completed or were terminated, 36 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 97 have an industry lead sponsor. The 10 most frequent:
This study is registered under Heidelberg Engineering GmbH, one of the names counted as EssilorLuxottica. Under that name alone:
Heidelberg Engineering GmbH is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
EssilorLuxottica has 1 study filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
9 of the studies in Macular Degeneration with a site in Italy that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT06373731Phase 3Stealth BioTherapeutics Inc.ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) | 2027-08 |
| NCT07064759Phase 34D Molecular TherapeuticsSingle Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration | 2027-11 |
| NCT06906003Fondazione G.B. Bietti, IRCCSVisual Rehabilitation and Depression in Visually Impaired Patients With AMD | 2026-12-02 |
| NCT07338461Heidelberg Engineering GmbHHigh Resolution Imaging OCT Study | 2026-12-30 |
Add all 9 to your calendar (.ics) → With an account.
Among the 97 studies in Macular Degeneration with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.
Participants will be imaged with different imaging modalities and scan protocols on all study devices.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed Age ≥ 18 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Imaging with the investigational device R1
Device: Autofluorescence Imaging · Device: Infrared reflectance imaging · Device: OCT imaging · Device: OCTA imaging
Imaging with the investigational device HighRes OCT
Device: Autofluorescence Imaging · Device: Infrared reflectance imaging · Device: OCT imaging · Device: OCTA imaging
Imaging with the approved device SPECTRALIS
Device: Autofluorescence Imaging · Device: Infrared reflectance imaging · Device: OCT imaging · Device: OCTA imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging, 30° Field of View
OCT Imaging Volume and Line Scans
OCT Angiography, volume and SCOUT scan
cSLO Image quality grading
Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful
Time frame: 6 months after image acquisition
Visability of key anatomical structures
Visibility of OCT image: 1. Difference in reflectivity between the outer retino-choroidal complex and vitreous 2. The vitreo-retinal interface 3. Difference in reflectivity between retinal nerve fiber layer and vitreous 4. Difference in reflectivity between plexiform layer and vitreous 5. Multiple layers within the outer retino-choroidal complex 6. The ganglion cell layer 7. Difference in reflectivity between outer nuclear layer and vitreous 8. External limiting membrane 9. Choroidal/scleral interface OCTA image: 1. Foveal avascular zone 2. Large vessels: 1st order vasculature, if applicable 3. Medium vessels: 2nd and 3rd order vasculature 4. Small vessels: between 3rd order vasculature and end capillaries 5. End capillaries
Time frame: 6 months after image acquisition
Safety Monitoring
Observation of possible adverse events
Time frame: from enrollment to study completion (expected 1 year after initiation)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 132 interventional studies with no phase under Macular Degeneration, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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