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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04787471
Other study ID # 2021-001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 3, 2021
Est. completion date July 15, 2025

Study information

Verified date February 2024
Source Price Vision Group
Contact Marianne Price, PhD
Phone 317-814-2990
Email mprice@cornea.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date July 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - With active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids. - Signed written informed consent. Exclusion Criteria: - Known sensitivity to treatment medications - Current condition that in the investigator's opinion could compromise safety or data integrity. - Pregnancy (including plan to become pregnant) or lactation during the course of the study

Study Design


Intervention

Combination Product:
30 minute photoactivation of riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes
10 minute photoactivation of riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes

Locations

Country Name City State
United States Price Vision Group Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Price Vision Group Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24. — View Citation

Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270. doi: 10.1016/j.ophtha.2017.03.052. Epub 2017 May 7. Erratum In: Ophthalmology. 2017 Dec;124(12 ):1878. — View Citation

Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2. — View Citation

Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06. — View Citation

Schaub F, Hou Y, Zhang W, Bock F, Hos D, Cursiefen C. Corneal Crosslinking to Regress Pathologic Corneal Neovascularization Before High-Risk Keratoplasty. Cornea. 2021 Feb 1;40(2):147-155. doi: 10.1097/ICO.0000000000002406. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary corneal neovascularization as a proportion of the total corneal area the cornea will be photographed and morphometric image analysis software will be used to measure corneal neovascularization as a proportion of the total corneal area. The proportion measured at baseline will be compared with the proportion measured at 6 months after treatment. 6 months
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