Corneal Crosslinking for Treatment of Corneal Neovascularization

Phase 2

Recruiting

• Conditions: Corneal Neovascularization
• Interventions: Combination Product: 10 minute photoactivation of riboflavin 0.1%; Combination Product: 30 minute photoactivation of riboflavin 0.1%

• Registration Number: NCT04787471
• Lead Sponsor: Price Vision Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-08
• Study Start: 2021-05-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-07-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 minute photoactivation	10 minute photoactivation of riboflavin 0.1%	photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes
30 minute photoactivation	30 minute photoactivation of riboflavin 0.1%	photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes

Primary Outcome Measures

Name	Time	Method
corneal neovascularization as a proportion of the total corneal area	6 months	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.

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States