Recruiting
Phase 2
Phase 3

Riboflavin

Sponsor:

Price Vision Group

Code:

NCT04787471

Conditions

Corneal Neovascularization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

30 minute photoactivation of riboflavin 0.1%

10 minute photoactivation of riboflavin 0.1%

Study Details

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.

Conditions

Corneal Neovascularization

Study ID

NCT04787471

Start date

May 3, 2021

Status verified date

Jul, 2025

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Jul 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 30 minute photoactivation

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

active comparator: 10 minute photoactivation

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

Interventions

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

Primary outcome measure

  • corneal neovascularization as a proportion of the total corneal area [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marianne Price, PhD

317-814-2990mprice@cornea.org

Locations

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Marianne Price, PhD

317-814-2990mprice@cornea.org

Principal Investigator:

Francis Price, Jr., MD

More Information

Sponsor

Price Vision Group

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Price Vision Group on 2025-07-31.