Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
This study tests a new miniature telescope that is implanted in the eye to help people with advanced age-related macular degeneration (AMD) who have significant vision loss in their central sight. The device uses a smaller surgical incision than previous versions. The research will evaluate whether it is safe and effective for improving vision in patients with late-stage AMD.
Key Objective: This trial is testing whether a smaller, next-generation implantable telescope can safely improve central vision in patients with moderate-to-severe vision loss from advanced AMD.
Who to Consider: Patients with moderate-to-severe central vision loss due to late-stage age-related macular degeneration who have exhausted other treatment options should consider enrolling.
Trial Parameters
Brief Summary
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Eligibility Criteria
Inclusion Criteria: 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: 1. lack of need of treatment for CNV over the past 6 months, and 2. lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and 3. lack of Retinal hemorrhage on exam over a 6-month period or longer 5. Agree to participate in post-operative visual training F