SING IMT implant for pseudophakic patients with advanced AMD
Prospective, MulticEnter, Randomized, International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
This study will test whether the SING IMT™ implant, placed either on top of or replacing an existing intraocular lens, can improve central vision in people with advanced AMD who already have IOLs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | VisionCare, Inc. Industry-sponsored |
| Locations | 12 sites (Marseille and 11 other locations) |
| Trial ID | NCT07164378 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥55) with late-stage bilateral AMD who are pseudophakic in both eyes for at least six months, have BCDVA between 20/80 and 20/800, adequate peripheral vision, ACD ≥2.5 mm, ECD ≥1600 cells/mm², and show at least a two-line ETDRS improvement with an external telescope simulator.
Not a fit: Patients unlikely to benefit include those with insufficient endothelial cell counts or shallow anterior chambers, visual acuity outside the 20/80–20/800 range, inability to demonstrate preoperative improvement with the simulator, or inadequate peripheral vision.
Why it matters
Potential benefit: If successful, the SING IMT™ could restore useful central distance vision and improve daily activities for some people with advanced AMD who previously had cataract surgery.
How similar studies have performed: Earlier implantable miniature telescope devices have shown meaningful visual-acuity and functional gains in advanced AMD, but using the SING IMT™ specifically in pseudophakic patients is a label-expansion approach with more limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille and 11 other locations
- 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)
- Augenklinik und Poliklinik des Universitätsklinikums — Würzburg, Germany (Recruiting)
- Ospedale Generale Regionale "F. Miulli" — Bari, Italy (Recruiting)
- IRCCS Humanitas — Bergamo, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (Recruiting)
- Presidio Ospedaliero Palagi — Florence, Italy (Recruiting)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Faustino Vidal Aroca
- Email: fvidalaroca@samsaravision.com
- Phone: +39 3476255836
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.