What is the mechanism of action of this treatment?

The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapy, photodynamic therapy, and the Implantable Miniature Telescope (IMT). Anti-VEGF therapy inhibits vascular endothelial growth factor to reduce abnormal blood vessel growth and leakage in the retina. Photodynamic therapy uses a light-activated drug to target and destroy abnormal blood vessels. The IMT magnifies images onto healthier parts of the retina, bypassing the damaged central macula, which is crucial for improving central vision in AMD patients and enhancing their ability to perform daily activities.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF injections, laser therapy, and photodynamic therapy. Anti-VEGF injections can cause eye pain, increased intraocular pressure, and in rare cases, retinal detachment or endophthalmitis. Laser therapy may result in scarring and loss of peripheral vision. Photodynamic therapy can lead to temporary vision changes and photosensitivity. The Implantable Miniature Telescope (IMT), which magnifies images onto healthier parts of the retina, can cause complications such as corneal edema, increased intraocular pressure, and may require additional surgeries.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These drugs work by inhibiting abnormal blood vessel growth and leakage in the retina. Another notable FDA-approved treatment is the Implantable Miniature Telescope (IMT), which magnifies images onto healthier parts of the retina to improve vision in patients with late-stage AMD. This device is particularly relevant as it shares a similar objective with the treatments being studied in the SING-IMT trial, aiming to enhance central vision by bypassing the damaged macula.

What other types of research exist?

Promising novel alternatives to the Implantable Miniature Telescope (IMT) for Age-Related Macular Degeneration (AMD) patients include: 1) Retinal prostheses, which are devices implanted to stimulate the retina and restore partial vision. 2) Gene therapy, which aims to correct genetic defects or introduce new genes to slow or reverse vision loss. 3) Stem cell therapy, which involves transplanting healthy retinal cells to replace damaged ones. 4) Pharmacological advancements, such as new anti-VEGF drugs or other agents targeting different pathways involved in AMD progression.

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Device

SING-IMT for Late-Stage Age-Related Macular Degeneration (CONCERTO Trial)

N/A

Recruiting

Research Sponsored by VisionCare, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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;

For the Non-Implanted Eye: Have adequate peripheral vision at the Pre-operative Visit to allow navigation

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12-months post-operatively (330-420 days)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from surgery, inflammation of the eye, infection risk increase due to surgery, changes in intraocular pressure which could affect vision quality and possible rejection of the implanted device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My non-implanted eye allows me to navigate safely.

Select...

I have severe eye damage in both eyes confirmed by a special eye test.

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I am 65 years old or older.

Select...

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

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I have severe eye damage in both eyes confirmed by a special eye test before surgery.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12-months post-operatively (330-420 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12-months post-operatively (330-420 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12-months post-operatively (330-420 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Outcome

Primary Safety Outcome

Secondary study objectives

Adverse Events

Anterior Chamber Depth

Best-corrected distance visual acuity (BCDVA)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SING-IMT ImplantedExperimental Treatment1 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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapy, photodynamic therapy, and the Implantable Miniature Telescope (IMT). Anti-VEGF therapy inhibits vascular endothelial growth factor to reduce abnormal blood vessel growth and leakage in the retina. Photodynamic therapy uses a light-activated drug to target and destroy abnormal blood vessels. The IMT magnifies images onto healthier parts of the retina, bypassing the damaged central macula, which is crucial for improving central vision in AMD patients and enhancing their ability to perform daily activities.