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New treatment option for Down Syndrome (DS)
Official title Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
ClinicalTrials.gov ID: NCT07135167
What this study is testing
What is Epi-ON corneal cross-linking (CXL)?
Epi-ON corneal cross-linking (CXL) is an investigational medicine, being studied as a potential treatment for down syndrome (ds).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following...
- Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme...
- Provide written informed consent and a signed HIPAA form. Pediatric people less than 14 years of age must sign an assent, and a parent or legal...
- Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)
You likely can't join if
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent...
- History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional...
See the full eligibility criteria
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedures.
- Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme fruste keratoconus based on topography, tomography, and slit lamp...
- Provide written informed consent and a signed HIPAA form. Pediatric people less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. If the subject has impaired consent...
- Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)
- Be willing and able to follow all instructions to the best of his/her abilities and comply with the schedule for follow-up visits.
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
- History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking...
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
- If female, pregnant, lactating or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. [NOTE: If female and capable of...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Canton, Georgia, United States
- Cumming, Georgia, United States
- Douglasville, Georgia, United States
- Lawrenceville, Georgia, United States
- Marietta, Georgia, United States
- Snellville, Georgia, United States
- Asheville, North Carolina, United States
- Chattanooga, Tennessee, United States
- Johnson City, Tennessee, United States
- Knoxville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Canton, Georgia, United States; Cumming, Georgia, United States; Douglasville, Georgia, United States; Lawrenceville, Georgia, United States; Marietta, Georgia, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.