Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
Recruiting now · Not applicable
Conditions studied: Age-Related Macular Degeneration, Geographic Atrophy
In brief
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).
Key facts
- Study ID
- NCT05438732
- Run by
- VisionCare, Inc.
- People needed
- 125
- Starts
- 2022-06-16
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-12-03
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be at least 65 years of age at the Pre-operative Visit;
- 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;
- 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;
- 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:
- lack of need of treatment for CNV over the past 6 months, and
- lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
- lack of Retinal hemorrhage on exam over a 6-month period or longer
- Agree to participate in post-operative visual training
- For the Implanted Eye:
- Have evidence of visually significant cataract at the Pre-operative Visit;
- 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:
- Have adequate peripheral vision at the Pre-operative Visit to allow navigation
You may not qualify if…
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
- Have any of the following conditions at the Pre-operative Visit:
- Stargardt macular dystrophy;
- Diabetic retinopathy;
- Untreated retinal tears;
- Retinal vascular disease;
- Optic nerve disease;
- History of retinal detachment;
- Intraocular tumor;
- Retinitis pigmentosa;
- History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit;
- Have known allergy to post-operative medications;
- History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;
- Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
- Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
- Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
- Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit
- For the Implanted Eye:
- Have central anterior chamber depth (ACD) <3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
- Have an Endothelial Cell Density (ECD) below:
- 2,000 cells per millimeter, if 65-84 years old;
- 1,800 cells per millimeter, if 85 years old or greater (based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit)
- Have a history of corneal stromal or endothelial dystrophies, including guttata;
- Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit;
- Have an Axial Length (AL) < 21 mm at the Pre-operative Visit;
Where it is running
- Loma Linda University — Loma Linda, California, United States (enrolling)
- Eye Physicians of Long Beach — Long Beach, California, United States (enrolling)
- Sarasota Retina Institute — Sarasota, Florida, United States (enrolling)
- Tallman Eye Associates — Lawrence, Massachusetts, United States (enrolling)
- Oakland Ophthalmic Surgery — Birmingham, Michigan, United States (enrolling)
- Vance Thompson Vision — Omaha, Nebraska, United States (enrolling)
- Atlantic Eye Physicians — Eatontown, New Jersey, United States (enrolling)
- Western Carolina Retinal Associates — Asheville, North Carolina, United States (enrolling)
- Cleveland Clinic | Cole Eye Institute — Cleveland, Ohio, United States (enrolling)
- Methodist Eye Associates | Houston Methodist — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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