Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome

Conditions

• Down Syndrome (DS)
• Forme Fruste Keratoconus (FFK)
• Keratoconus
• Pellucid Marginal Degeneration

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epi-ON corneal cross-linking (CXL) — COMBINATION_PRODUCT
  Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light for 20 minutes.

Study Details

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. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be 8 years of age or older and have a diagnosis of Down syndrome. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).

Key Dates

Start date

Aug 1, 2025

Status verified

Jan 2026

Primary completion

Nov 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

225 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Enrolled and treated subject arm
  Epi-ON corneal cross-linking (CXL)

Primary Outcome Measure

The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes. [ Time Frame: From enrollment to the end of treatment at 6 months. ]

Central Contacts

• LuAnn Bryant
  770-804-1684
  [email protected]

Locations (12)

Find similar trials in Atlanta, GA

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