Corneal Crosslinking for Treatment of Corneal Neovascularization

Corneal Neovascularization Clinical Trial

Official title:

Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04787471
• Other study ID #: 2021-001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

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