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Theranostic Guided Riboflavin/UV-A Corneal Cross-linking (ARGO)

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ClinicalTrials.gov Identifier: NCT05457647
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Regensight

Brief Summary:
This is a clinical study consisting of a study arm to assess the performance of the theranostic software module (Research Use Only) of a CE marked (CE1936) UV-A medical device, C4V CHROMO4VIS™, in order to validate its use for theranostic-guided corneal cross-linking treatment of keratoconus and corneal ectasia. The study hypothesis is that theranostic-guided riboflavin/UV-A corneal cross-linking with the C4V CHROMO4VIS™ system is safe and can estimate treatment efficacy during operation, regardless of treatment protocol, i.e., either with or without epithelial removal.

Condition or disease Intervention/treatment Phase
Keratoconus Device: Riboflavin/UV-A corneal cross-linking Not Applicable

Detailed Description:

Keratoconus is a naturally-occurring ocular condition characterized by progressive thinning and steepening of the central cornea, resulting in corneal optical irregularities with increasing myopia, irregular astigmatism, corneal opacity and consequential loss of visual acuity. Riboflavin/UV-A corneal cross-linking is a procedure used to biomechanically stabilize the weak cornea in keratoconus and to slow down or halt the clinical progression of this disease. Theranostics is an emerging therapeutic paradigm that enables monitoring of image-guided therapy in clinic through the use of a theranostic module that makes use of real-time non-invasive molecular analysis of the tissue being treated to achieve optimal treatment outcomes in the management of disease.

The theranostic software module of the C4V CHROMO4VIS™ medical device is able to measure the concentration of riboflavin into the cornea during treatment and to provide the surgeon with an objective assessment of treatment efficacy.

The scope of this study is to validate the theranostic imaging biomarker score by assessing the change of corneal topography Kmax value at 1-year postoperatively. The 1-year follow-up is long enough to provide scientific evidence of the safety and efficacy of the theranostic UV-A medical device in question. A pre-operative examination will ensure that every interested and willing participant fulfils the inclusion criteria of this study. Post-operative examinations will be carried out after 1 week, 1 month, 3 months, 6 months and 12 months.

This is a multi-center clinical trial. Eligible participants will be stratified with allocation ratio 1:1 into either treatment protocol (EpiOn and EpiOFF Thera-CXL) using a computer-generated stratification plan with blocks. Two different blocks are created, which include eyes with Kmax steeper or flatter than 54.0 D to allocate patients with comparable baseline Kmax values in either treatment protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Theranostic Guided Riboflavin/UV-A Corneal Cross-linking for Treatment of Keratoconus
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : December 13, 2023
Estimated Study Completion Date : December 13, 2023


Arm Intervention/treatment
Experimental: Riboflavin/UV-A corneal cross-linking monitored by theranostic software module
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Device: Riboflavin/UV-A corneal cross-linking
Corneal cross-linking procedure will be performed using the theranostic software module of the C4V CHROMO4VIS™ system in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop will be done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea will be monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score will be performed by the C4V CHROMO4VIS™ system during UV-A irradiation.




Primary Outcome Measures :
  1. Validation of the theranostic score [ Time Frame: 12 months ]
    The aim of this study is to validate the Theranostic Imaging Biomarker for theranostic-guided corneal corneal cross-linking (CXL) in patients with keratoconus


Secondary Outcome Measures :
  1. Corneal topography outcome [ Time Frame: 12 months ]
    Change of Maximum Simulated Keratometry

  2. Treatment safety [ Time Frame: 12 months ]
    Change of Endothelial Cell Density


Other Outcome Measures:
  1. Manifest Refraction change [ Time Frame: 12 months ]
    Change of Manifest Refraction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

criteria for inclusion in the clinical trial are those currently referred to as the golden standard for the treatment of corneal cross-linking. The criterion to determine progression of keratoconus is based on providing at least one of the following evidences:

  • at least two Placido disk corneal topography measurements showing at least +1.00 D steepening of the Kmax value in the last year or longer interval period.
  • at least two manifest refraction measurements showing at least -0.50 D change in spherical equivalent refraction in the last year or longer interval period.
  • at least two central corneal thickness (CCT) measurements showing at least -10 µm change in in the last year or longer interval period.

Exclusion Criteria:

  • Anterior corneal curvature steeper than 63 D;
  • Corneal thickness thinner than 400 µm;
  • Corneal scarring;
  • Descemetocele;
  • History of herpetic keratitis;
  • Concomitant eye diseases;
  • Inflammatory eye diseases;
  • Glaucoma;
  • Cataract;
  • Nistagmus;
  • Pregnancy;
  • Breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05457647


Contacts
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Contact: Marco Lombardo, MD, PhD +393313438300 clinicaltrials@regensight.com

Locations
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Italy
Azienda Ospedaliera Universitaria Mater Domini - Università Magna Graecia di Catanzaro Recruiting
Catanzaro, Italy, 88100
Contact: Vincenzo Scorcia, MD    0961/3647135    vscorcia@unicz.it   
Azienda Ospedaliera Universitaria Careggi, Università di Firenze Recruiting
Firenze, Italy, 50134
Contact: Rita Mencucci    055/7946992    rita.mencucci@unifi.it   
Azienda Ospedaliera Universitaria Policlinico G. Martino, Università di Messina Recruiting
Messina, Italy, 98124
Contact: Anna Maria Roszkowska    090/2212279    anna.roszkowska@unime.it   
Sponsors and Collaborators
Regensight
Investigators
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Principal Investigator: Vincenzo Scorcia, MD Azienda Ospedaliera Universitaria Mater Domini - Università Magna Graecia di Catanzaro
Additional Information:
Publications:
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Responsible Party: Regensight
ClinicalTrials.gov Identifier: NCT05457647    
Other Study ID Numbers: RSKC001
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regensight:
theranostics
riboflavin
UV-A light
corneal cross-linking
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents