Corneal Crosslinking for Treatment of Corneal Neovascularization

Price Vision Group

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Corneal Neovascularization

Treatments: Combination Product: 10 minute photoactivation of riboflavin 0.1%; Combination Product: 30 minute photoactivation of riboflavin 0.1%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04787471

2021-001

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

30 minute photoactivation

Active Comparator group

Description:

photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes

Treatment:

Combination Product: 30 minute photoactivation of riboflavin 0.1%

10 minute photoactivation

Active Comparator group

Description:

photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes

Treatment:

Combination Product: 10 minute photoactivation of riboflavin 0.1%