Ireland
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Recruiting Not applicable

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

NCT05438732 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2022-06-16
Last updated
2024-12-03

Condition(s) studied

Age-Related Macular DegenerationGeographic Atrophy

Investigational drug(s) / intervention(s)

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

smaller incision, new generation implantable miniature telescope (SING-IMT): The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 For the Implanted Eye: 6. Have evidence of visually significant cataract at the Pre-operative Visit; 7. 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: 8. Have adequate peripheral vision at the Pre-operative Visit to allow navigation Exclusion Criteria: 1. Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device; 2. Have any of the following conditions at the Pre-operative Visit: 1. Stargardt macular dystrophy; 2. Diabetic retinopathy; 3. Untreated retinal tears; 4. Retinal vascular disease; 5. Optic nerve disease; 6. History of retinal detachment; 7. Intraocular tumor; 8. Retinitis pigmentosa; 3. History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP \>22 mmHg at the Pre-operative Visit; 4. Have known allergy to post-operative medications; 5. History of eye rubbing or an ocular condition that predisposes subject to eye rubbing; 6. Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit; 7. Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety; 8. 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; 9. 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: 10. 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; 11. Have an Endothelial Cell Density (ECD) below: 1. 2,000 cells per millimeter, if 65-84 years old; 2. 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) 12. Have a history of corneal stromal or endothelial dystrophies, including guttata; 13. Have Myopia \> 6.0 D or Hyperopia \> 4.0 D by Manifest Refraction at the Pre-operative Visit; 14. Have an Axial Length (AL) \< 21 mm at the Pre-operative Visit; 15. Have a narrow angle defined as \< grade 2 on the Schaffer scale at the Pre-operative Visit; 16. Ongoing Inflammatory ocular disease at the Pre-operative Visit; 17. Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit; 18. Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery; 19. Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes; For the Non-Implanted Eye: 20. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

Primary outcome measure(s)

  • Primary Effectiveness Outcome — Approximately 12-months post-operatively (330-420 days)
    Proportion of study eyes with an improvement of 10 or more ETDRS letters (0.2 logMAR) in either BCDVA or BCNVA at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
  • Primary Safety Outcome — Approximately 12-months post-operatively (330-420 days)
    Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)

Trial sites (10)

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

More VisionCare, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05438732 on ClinicalTrials.gov ↗ ← All trials in the USA