Clinical trial NCT04787471: Corneal Crosslinking for Treatment of Corneal Neovascularization
Official title: Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Corneal Neovascularization
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
Collaborators: name: Cornea Research Foundation of America
First posted: 2021-03-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: corneal neovascularization as a proportion of the total corneal area
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.