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SING-IMT for Late-Stage Age-Related Macular Degeneration (CONCERTO Trial)
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.
CONCERTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCONCERTO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CONCERTO Trial Design
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Who is running the clinical trial?
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- 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.You have no retinal hemorrhage over a 6-month period or longer.I have severe eye damage in both eyes confirmed by a special eye test.You have no active exudative fluid on OCT over the past 6 months.I am 65 years old or older.My vision is between 20/160 and 20/800 due to advanced AMD.I agree to do visual training after surgery.I have severe eye damage in both eyes confirmed by a special eye test before surgery.My non-implanted eye allows me to navigate safely.My eyes have been stable without any special treatment for the last 6 months.I am 65 years old or older.
- Group 1: SING-IMT Implanted
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What state do they live in?
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