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

(CONCERTO Trial)

Recruiting at16 trial locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VisionCare, Inc.

Disqualifiers: Cognitive impairment, Diabetic retinopathy, Glaucoma, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a tiny telescope implanted in the eye to help people with severe vision loss from late-stage AMD. The telescope magnifies images to improve vision by using healthy parts of the eye.

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 data supports the effectiveness of the treatment SING-IMT for late-stage age-related macular degeneration?

Research shows that implantable miniature telescopes (IMT) have been effective in improving vision for patients with age-related macular degeneration, with studies reporting both medium-term and long-term benefits in visual acuity (sharpness of vision). ^{1 2 3 4 5}

Is the SING-IMT treatment safe for humans?

The SING-IMT has been studied for safety in patients with age-related macular degeneration, showing that it generally has a good safety profile. In a study, the most common issue was corneal edema (swelling of the clear front part of the eye), but overall, it showed lower cell loss in the eye compared to the first-generation device. ^{1 2 3 5 6}

How is the SING-IMT treatment different from other treatments for late-stage age-related macular degeneration?

The SING-IMT treatment is unique because it involves implanting a miniature telescope inside the eye, which helps improve vision by directing light to healthy parts of the retina. This approach is different from other treatments that typically involve injections or medications. ^{1 2 3 5 7}

Research Team

Rebecca J Kammer, OD, PhD

Principal Investigator

Samsara Vision Inc.

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• SING-IMT (Device)

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.

Participant Groups

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 China for the following indications:

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. New Zealand 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intraocular telescopic lens evaluation in patients with age-related macular degeneration. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Implantable Miniature Telescope for macular degeneration. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™). [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Optical-Quality Assessment of a Miniaturized Intraocular Telescope. [2023]