Multicenter Clinical Study of the SING-IMT in Patients With Late-stage AMD (CONCERTO)

VisionCare

Status: Enrolling

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05438732

CDV-SNG-21-001

Details and patient eligibility

About

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).

Full description

Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist

Enrollment: 125 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

SING-IMT Implanted

Experimental group

Description:

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

Treatment:

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