Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

NCT04731727 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 0000
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.

Conditions

Keratoconus, Unstable

Outcome Measures

Primary Outcomes (3)

• Change in Best Corrected Visual Acuity

  Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff

  Baseline and 1 year

• Change in Uncorrected Visual Acuity

  Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician

  Baseline and 1 year

• Occurrence of Adverse Events

  Surgeon notes any occurrence of adverse events related to the treatment

  Through study completion, an average of 1 year

Study Arms (1)

Cross linking treatment for corneal thinning

EXPERIMENTAL

Cornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light.

Drug: Riboflavin

Interventions

Riboflavin DRUG

Corneal cross linking achieved by combination of Riboflavin and ultraviolet light

Also known as: Ultra violet light

Cross linking treatment for corneal thinning

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of central or inferior corneal steepening
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
• Fleischer ring
• Vogt's striae
• Decentered corneal apex
• Munson's sign
• Rizutti's sign
• Apical corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography
• Steepest keratometry (Kmax) value \> or = 47.20 D
• I-S keratometry difference \> 1.5 D on the Orbscan map
• Posterior corneal elevation \> 16 microns
• Thinnest corneal point \< 485 microns

You may not qualify if:

• Eyes classified as either normal or atypical normal on the severity grading scheme
• Corneal pachymetry at the screening exam that is \< 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or \< 300 microns when the hypotonic riboflavin will be used.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
• Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
• Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Sponsors & Collaborators

• Kent Wellish MD: lead

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin; Ultraviolet Rays

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Ionizing; Radiation, Nonionizing; Sunlight; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Kent L Wellish, MD

  Wellish Vision Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony F Sterrett

CONTACT

702-932-4265; tsterrett@wellish.com

Kent L Wellish, MD

CONTACT

702-339-2020; klwellish@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President and Medical Director

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 1, 2021
• Study Start: June 30, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share