Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD (NCT05438732)

🧪 Interventions in This Study

• smaller incision, new generation implantable miniature telescope (SING-IMT) (DEVICE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Be at least 65 years of age at the Pre-operative Visit;
2. Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
3. Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
4. Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
5. lack of need of treatment for CNV over the past 6 months, and
6. lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
7. lack of Retinal hemorrhage on exam over a 6-month period or longer
8. Agree to participate in post-operative visual training For the Implanted Eye:
9. Have evidence of visually significant cataract at the Pre-operative Visit;
10. Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment For the Non-Implanted Eye:
11. Have adequate peripheral vision at the Pre-operative Visit to allow navigation

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 Sites)

• Loma Linda University — Loma Linda, California
• Eye Physicians of Long Beach — Long Beach, California
• Sarasota Retina Institute — Sarasota, Florida
• Tallman Eye Associates — Lawrence, Massachusetts
• Oakland Ophthalmic Surgery — Birmingham, Michigan
• Vance Thompson Vision — Omaha, Nebraska
• Atlantic Eye Physicians — Eatontown, New Jersey
• Western Carolina Retinal Associates — Asheville, North Carolina
• Cleveland Clinic | Cole Eye Institute — Cleveland, Ohio
• Methodist Eye Associates | Houston Methodist — Houston, Texas

📞 Contact the Study Coordinator

Phone: (714) 728-1575

Email: rkammer@samsaravision.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.