SING-IMT for Late-Stage Age-Related Macular Degeneration

(CONCERTO Trial)

Recruiting at 16 trial locations

Overseen By Colleen Collier

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VisionCare, Inc.

Disqualifiers: Cognitive impairment, Diabetic retinopathy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 1 day

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, smaller implantable telescope, the SING-IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), designed to assist individuals with moderate to severe central vision loss due to late-stage age-related macular degeneration (AMD). The trial aims to determine the safety and effectiveness of this device when implanted during routine cataract surgery. It seeks participants who have significant vision loss from AMD, have a cataract, and have remained stable without certain eye conditions for the past six months. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could enhance vision outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the SING-IMT is safe for patients with late-stage age-related macular degeneration?

Research shows that the Smaller-Incision New-Generation Implantable Miniature Telescope (SING-IMT) is undergoing safety testing for treating advanced age-related macular degeneration (AMD). One study found that patients who received the SING-IMT experienced improved vision without major safety concerns. Surgeons placed the device in the eye during regular cataract surgery, and most patients tolerated the procedure well.

Another study found that patients generally tolerated the SING-IMT well over three months, with no serious negative effects directly linked to the implant. This suggests the treatment might be safe for people with advanced AMD, but ongoing research will provide more information about its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SING-IMT because it offers a novel approach to treating late-stage age-related macular degeneration (AMD). Unlike standard treatments like anti-VEGF injections that work by inhibiting blood vessel growth, SING-IMT is an implantable device used during cataract surgery, potentially allowing for a more sustained and targeted intervention. This device is implanted directly into the eye through a small incision, which could provide continuous benefits without the need for frequent injections, making it a potentially more convenient and long-lasting treatment option for patients.

What evidence suggests that the SING-IMT is effective for late-stage age-related macular degeneration?

Research has shown that the new, smaller implantable telescope, called SING-IMT, offers promising results for people with advanced age-related macular degeneration (AMD). In studies, patients who received the SING-IMT during routine cataract surgery experienced improved vision. The device enlarges images onto healthy parts of the retina, enhancing central vision. Six months after the procedure, patients in these studies had better vision and quality of life. While more research is needed, these early findings suggest that SING-IMT could be a helpful option for those with severe vision loss due to AMD. ^{1 4 6 7 8}

Who Is on the Research Team?

Rebecca J Kammer, OD, PhD

Principal Investigator

Samsara Vision Inc.

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with late-stage age-related macular degeneration (AMD) causing severe vision loss. Participants must have stable AMD without recent bleeding or active fluid in the retina, and be monitored by an eye doctor for at least 6 months. They should not have cognitive impairments that affect training for a new visual device, significant myopia/hyperopia, previous eye surgeries, uncontrolled glaucoma, or allergies to post-op meds.

Inclusion Criteria

I haven't needed treatment for CNV in the last 6 months.

I agree to attend training with a vision specialist to use a special telescope and improve my reading ability.

My vision is between 20/160 and 20/800 due to AMD.

Exclusion Criteria

Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device

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, Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit, Ongoing Inflammatory ocular disease at the Pre-operative Visit, Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit, 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, Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes, For the Non-Implanted Eye: Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo out-patient surgery to implant the SING-IMT during routine cataract surgery

1 day

1 visit (in-person)

Post-operative Follow-up

Participants return for 5 post-operative follow-up visits to monitor safety and effectiveness

12 months

5 visits (in-person)

Rehabilitation/Training

Participants have up to 12 rehabilitation/training visits with a low vision specialist

12 months

Up to 12 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SING-IMT

Trial Overview The study tests a smaller incision implantable miniature telescope (SING-IMT) designed to improve central vision in patients with severe vision loss from AMD. It involves pre-operative training with low vision specialists and post-operative visual training to adapt to the device.

How Is the Trial Designed?

Group I: SING-IMT Implanted Experimental Treatment 1 Intervention

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

SING-IMT is already approved in European Union, China for the following indications:

Approved in European Union as SING IMT for:

• Late-stage age-related macular degeneration (AMD)

Approved in China as SING IMT for:

• Late-stage age-related macular degeneration (AMD)

Who Is Running the Clinical Trial?

VisionCare, Inc.

Lead Sponsor

Trials

10

Recruited

1,200+

ORA, Inc.

Industry Sponsor

Trials

72

Recruited

9,200+

Stuart Abelson

ORA, Inc.

Chief Executive Officer since 2007

BSc in Neuroscience from Bates College, MBA from Northwestern University

Dr. Gustavo De Moraes

ORA, Inc.

Chief Medical Officer since 2022

MD, PhD in Ophthalmic Sciences, MPH in Biostatistics

Published Research Related to This Trial

In a clinical trial involving 3 patients with age-related macular degeneration, the implantable miniaturized telescope (IMT) showed improvements in both distance and near vision over 18 months.

Despite the visual improvements, the IMT did not significantly enhance the patients' ability to perform daily activities, highlighting the need for careful patient selection and informed consent before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. Kaşkaloğlu, M., Uretmen, O., Yağci, A.[2019]

In a study involving 40 patients with stable dry-type age-related macular degeneration (ARMD), the implantation of a 3.0x intraocular miniaturized telescope (IMT) significantly improved both distance and near visual acuity after one year, with mean uncorrected distance visual acuity improving from 0.9 to 0.6 logMAR and near visual acuity from 0.8 to 0.4 logMAR.

While the procedure was generally well-tolerated, with the corneal endothelium showing good tolerance, there were some complications: 6 cases required explantation and 14 patients experienced adverse effects, 7 of which were persistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular telescopic lens evaluation in patients with age-related macular degeneration. Alió, JL., Mulet, EM., José, M., et al.[2022]

In a study of 217 patients with end-stage age-related macular degeneration, the implantable miniature telescope (IMT) showed a significant improvement in best-corrected distance visual acuity (BCDVA) over 60 months, with an average gain of 2.41 lines across all participants.

Younger patients (ages 65 to <75) experienced better visual retention and fewer adverse events compared to older patients (≥75), indicating that age may influence the safety and efficacy of the IMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration. Boyer, D., Freund, KB., Regillo, C., et al.[2020]

The SING IMT™ miniaturized telescope shows promising optical performance for improving vision in patients with age-related macular degeneration (AMD), with even optical transmission across the visible spectrum and minimal aberrations.

In vitro testing indicates that the telescope functions effectively as a diverging lens, which could enhance retinal image magnification, making it a viable treatment option for late-stage AMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical-Quality Assessment of a Miniaturized Intraocular Telescope. Nepita, I., Raimondi, R., Piazza, S., et al.[2023]

In a study of patients with end-stage Age-related macular degeneration, the SING IMT™ telescope prosthesis showed significant improvements in visual acuity, with 70.83% of patients gaining at least 2 lines of best-corrected distance visual acuity after 3 months.

The SING IMT™ demonstrated lower endothelial cell density loss compared to the first-generation IMT™, indicating improved safety while maintaining similar visual outcomes, although corneal edema was the most common complication observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™). Toro, MD., Vidal-Aroca, F., Montemagni, M., et al.[2023]

A patient with neovascular age-related macular degeneration successfully managed recurrent choroidal neovascularization after receiving an implantable miniature telescope, highlighting the potential for this treatment in similar cases.

Intravitreal injections of anti-vascular endothelial growth factor can be safely administered in eyes with a telescope, using standard ocular coherence tomography for monitoring, which suggests a feasible approach for managing complications in such patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-vascular endothelial growth factor injection technique for recurrent exudative macular degeneration in a telescope-implanted eye. Joondeph, BC.[2015]

The Implantable Miniature Telescope has shown promising results in improving visual acuity and quality of life for patients with bilateral end-stage macular degeneration, with 89% of participants gaining two or more lines of visual acuity after 6 months.

The device was generally safe and well tolerated, although there was a reduction in endothelial cell density post-surgery, which was manageable with careful surgical techniques and comprehensive patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implantable Miniature Telescope for macular degeneration. Lane, SS., Kuppermann, BD.[2007]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024171472

Smaller-incision new-generation implantable miniature ... Age-macular degeneration (AMD) is an eye condition involving a progressive accumulation of drusen on the macula and/or pigmentary abnormalities, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37920982/

Smaller-Incision new-generation implantable miniature ... ... and quality of life which have been deteriorated by late-stage macular degeneration. ... AMD; implantable miniature telescope; late-stage AMD ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05438732

Multicenter Clinical Study of the SING-IMT in Patients with ... Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD (CONCERTO) ... Associated with End-stage Age-related Macular Degeneration (AMD).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39839515/

Smaller-incision new-generation implantable miniature ... Smaller-incision new-generation implantable miniature telescope in late-stage age-related macular degeneration: 6 month outcomes. Heliyon ...

5. samsaravision.com samsaravision.com/investors/news-events/press-releases/detail/75/samsara-vision-expands-u-s-and-puerto-rico-clinical-study

Press Releases Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the number one cause of ...

6. samsaravision.com samsaravision.com/press-releases/detail/73/samsara-vision-announces-positive-six-month-visual-and

Samsara Vision Announces Positive Six-Month Visual and ... Age-related macular degeneration (AMD) is a leading cause of ... There is no cure for late-stage AMD and the SING IMT® does not return ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36675446/

Three-Month Safety and Efficacy Outcomes for the Smaller- ... ... Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™) ... associated with end-stage Age-related macular degeneration (AMD).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05438732

Multicenter Clinical Study of the SING-IMT in Patients with ... Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD (CONCERTO) ... Associated with End-stage Age-related Macular Degeneration (AMD).