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

NCT05438732 | Recruiting FDA Device

• 1 other identifier: CDV-SNG-21-001
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 10

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).

Conditions

Age-Related Macular Degeneration; Geographic Atrophy

Keywords

cataract; best-corrected distance visual acuity

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Outcome

  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

  Approximately 12-months post-operatively (330-420 days)

• Primary Safety Outcome

  Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)

  Approximately 12-months post-operatively (330-420 days)

Secondary Outcomes (6)

• Best-corrected distance visual acuity (BCDVA)

  Approximately 12-months post-operatively (330-420 days)

• Best-corrected near visual acuity (BCNVA)

  Approximately 12-months post-operatively (330-420 days)

• Anterior Chamber Depth

  Approximately 12-months post-operatively (330-420 days)

• IMT position

  Approximately 12-months post-operatively (330-420 days)

• Adverse Events

  Approximately 12-months post-operatively (330-420 days)

Study Arms (1)

SING-IMT Implanted

EXPERIMENTAL

the implanted eye will be the study eye which receives the SING-IMT. Implantation will occur during routine cataract surgery using a proprietary delivery system (loading cartridge and injector), via an approximately 6.5mm incision

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

Interventions

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

The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)

SING-IMT Implanted

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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;

Sponsors & Collaborators

• VisionCare, Inc.: lead
• ORA, Inc.: collaborator

Study Sites (10)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Eye Physicians of Long Beach

Long Beach, California, 90815, United States

RECRUITING

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

RECRUITING

Tallman Eye Associates

Lawrence, Massachusetts, 01841, United States

RECRUITING

Oakland Ophthalmic Surgery

Birmingham, Michigan, 48009, United States

RECRUITING

Vance Thompson Vision

Omaha, Nebraska, 68137, United States

RECRUITING

Atlantic Eye Physicians

Eatontown, New Jersey, 07724, United States

RECRUITING

Western Carolina Retinal Associates

Asheville, North Carolina, 28803, United States

RECRUITING

Cleveland Clinic | Cole Eye Institute

Cleveland, Ohio, 44195, United States

RECRUITING

Methodist Eye Associates | Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy; Cataract

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Study Officials

• Rebecca J Kammer, OD, PhD

  Samsara Vision Inc.

  STUDY DIRECTOR

Central Study Contacts

Rebecca Kammer, OD, PhD

CONTACT

+1 (714) 728-1575; rkammer@samsaravision.com

Colleen Collier

CONTACT

+1 (609) 213-9420; ccollier@samsaravision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: since the IMT has a unique appearance in the eye, it cannot be masked to the Investigator or to the patient
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Effectiveness: one-sided asymptotic normal test Safety: one-sided t-test

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 30, 2022
• Study Start: June 16, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)