Eye implant aims to restore sight in advanced AMD patients
NCT ID NCT07164378
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a small telescope-like implant called SING IMT™ for people with advanced age-related macular degeneration (AMD) who have poor central vision in both eyes. The device is placed inside the eye during surgery, either replacing or sitting in front of the existing lens. Researchers will check if it improves vision and is safe for 44 participants aged 55 and older.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SING IMT™ implantable miniature telescope
- What this could lead to
- If successful, this device could help people with advanced AMD see better up close and far away, improving daily activities like reading and recognizing faces.
- What could go wrong
- This is a small, early-stage study with only 44 people. The device requires eye surgery, which carries risks like infection or vision loss. It does not cure AMD or restore normal vision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be 55 years of age or older; 2. Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes; 3. Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment; 4. BCDVA no better than 20/80 and no worse than 20/800 in both eyes. 5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation. 6. Achieve using the ETS, at least 2-lines (10 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. 7. Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes. 8. Have an ECD of at least 1600 cells per square mm in both eyes. 9. Be willing to participate in a postoperative training program for the use of the SING IMT™ implant. 10. Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed. 11. Patient is registered with the national social security or equivalent in the country where consent is signed 12. A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 13, Not a woman of childbearing potential (WOCBP): A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through to the end of the study Exclusion Criteria: A. Bilateral Ocular Conditions (affecting both eyes): 1. Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months. 2. Diabetic retinopathy. 3. Retinal vascular diseases. 4. History of retinal detachment. 5. Retinitis pigmentosa. 6. Intraocular tumor. 7. Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata. 8. Patient predisposing to eye rubbing B. Surgical Eye Conditions: 9. Narrow angle (i.e., \< Schaffer grade 2). 10. Axial length \<21 mm or \>26 mm. 11. Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis. 12. Plate haptic shape IOL implanted. 13. Vitrectomized eye. 14. Zonular weakness, instability, presence of pseudoexfoliation. 15. Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization. 16. Any IOL already implanted in the sulcus. 17. Presence of toric or multifocal IOL types. 18. Optic Nerve Disease C. Systemic or Other General Conditions: 19. A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP \>22 mmHg. 20. Known sensitivity to post-operative medications. 21. Significant communication impairment or severe neurological disorders. 22. Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study. 23. Any condition or situation that, in the opinion of the investigator, may: * Put the subject at significant risk, * Confound the clinical investigation results, or * Interfere significantly with the subject's participation in the study. 24. Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
12 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Asklepios Augenklinik Nord-Heidberg
RECRUITINGHamburg, Germany
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Augenklinik Sulzbach
RECRUITINGSulzbach, Germany
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Augenklinik und Poliklinik des Universitätsklinikums
RECRUITINGWürzburg, Germany
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Azienda Ospedaliero-Universitaria di Ferrara
RECRUITINGFerrara, Italy
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CHU de Strasbourg
RECRUITINGStrasbourg, France
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Centre d'Ophtalmologie Paradis-Monticelli
RECRUITINGMarseille, France
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Hélios Ophtalmologie
RECRUITINGSaint-Jean-de-Luz, France
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IRCCS Humanitas
RECRUITINGBergamo, Italy
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MVZ Augenklinik Petrisberg GmbH
RECRUITINGTrier, Germany
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Ospedale Generale Regionale "F. Miulli"
RECRUITINGBari, Italy
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Policlinico Universitario Fondazione Agostino Gemelli
RECRUITINGRoma, Italy
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Presidio Ospedaliero Palagi
RECRUITINGFlorence, Italy
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