SING IMT implant for pseudophakic patients with advanced AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, international, multicenter trial enrolls adults with late-stage bilateral AMD who already have intraocular lenses in both eyes and limited central vision. Participants are randomized to receive the SING IMT™ as an add-on device placed over the existing IOL or to have their existing IOL replaced by the device. Key eligibility includes age ≥55, bilateral geographic atrophy or disciform scar with foveal involvement, best-corrected distance visual acuity between 20/80 and 20/800, minimum anterior chamber depth and endothelial cell density, and a demonstrated two-line improvement with an external telescope simulator. Outcomes focus on device safety, changes in visual acuity and function, and postoperative rehabilitation to support regulatory label expansion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre d'Ophtalmologie Paradis-Monticelli
  Marseille, France Recruiting
• Hélios Ophtalmologie
  Saint-Jean-de-Luz, France Recruiting
• CHU de Strasbourg
  Strasbourg, France Recruiting
• Asklepios Augenklinik Nord-Heidberg
  Hamburg, Germany Recruiting
• Augenklinik Sulzbach
  Sulzbach, Germany Recruiting
• MVZ Augenklinik Petrisberg GmbH
  Trier, Germany Recruiting

Study contacts

• Study coordinator: Faustino Vidal Aroca
• Email: fvidalaroca@samsaravision.com
• Phone: +39 3476255836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.