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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
lack of need of treatment for CNV over the past 6 months,
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12-months post-operatively (330-420 days)
Awards & highlights

CONCERTO Trial Summary

This trial is testing a new, smaller telescope implant to see if it is safe and effective in people with late-stage age-related macular degeneration.

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.Check my eligibility
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.See study design
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.

CONCERTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't needed treatment for CNV in the last 6 months.
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I agree to attend training with a vision specialist to use a special telescope and improve my reading ability.
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My vision is between 20/160 and 20/800 due to AMD.
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My non-implanted eye allows me to navigate safely.
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I have severe eye damage in both eyes confirmed by a special eye test.
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My eyes have been stable without any special treatment for the last 6 months.
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I am 65 years old or older.
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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 agree to do visual training after surgery.
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I am 65 years old or older.

CONCERTO Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Outcome
Primary Safety Outcome
Secondary outcome measures
Adverse Events
Anterior Chamber Depth
Best-corrected distance visual acuity (BCDVA)
+3 more

CONCERTO 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

Find a Location

Who is running the clinical trial?

ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,911 Total Patients Enrolled
VisionCare, Inc.Lead Sponsor
9 Previous Clinical Trials
1,082 Total Patients Enrolled
Rebecca J Kammer, OD, PhDStudy DirectorSamsara Vision Inc.

Media Library

SING-IMT (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05438732 — N/A
Age-Related Macular Degeneration Research Study Groups: SING-IMT Implanted
Age-Related Macular Degeneration Clinical Trial 2023: SING-IMT Highlights & Side Effects. Trial Name: NCT05438732 — N/A
SING-IMT (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438732 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have any available openings for participants?

"According to clinicaltrials.gov, this trial is actively searching for potential participants; the protocol was first uploaded on June 16th 2022 and has since been reviewed and revised as of August 5th 2022."

Answered by AI

How many locales can one access this research endeavor?

"Trial participants can be accepted at a total of 11 medical centres, the most notable being Asheville Eye Associates in North carolina, Sarasota Retina Institute in Florida and University Station Clinic in Wisconsin."

Answered by AI

What are the research objectives of this experiment?

"This trial's primary goal is to measure the safety of a newly developed therapy over 12 months post-operation (330-420 days). Secondary objectives comprising this study are Adverse Events, Intraocular Lens Tilt and Centration at Visit 5, as well as Posterior Capsule Opacification Rates in observed eyes at Follow Up Visit 5."

Answered by AI

To what extent is the enrollment of participants progressing in this research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was published on June 16th 2022, is actively recruiting patients. The study needs to enroll 125 individuals from 8 unique sites."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What state do they live in?
California
~0 spots leftby Apr 2024