Corneal Crosslinking for Treatment of Corneal Neovascularization

NCT04787471 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2021-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

30 minute photoactivation

ACTIVE COMPARATOR

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

Combination Product: 30 minute photoactivation of riboflavin 0.1%

10 minute photoactivation

ACTIVE COMPARATOR

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

Combination Product: 10 minute photoactivation of riboflavin 0.1%

Interventions

30 minute photoactivation of riboflavin 0.1% COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes

30 minute photoactivation

10 minute photoactivation of riboflavin 0.1% COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes

10 minute photoactivation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Price Vision Group: lead
• Cornea Research Foundation of America: collaborator

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 28655538 BACKGROUND

• 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.

  PMID: 28495149 BACKGROUND

• 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.

  PMID: 29203068 BACKGROUND

• 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.

  PMID: 23062001 BACKGROUND

• 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.

  PMID: 33395116 BACKGROUND

• Price FW Jr, Tefasse Z, Frances KD, Feng MT, Gang A, Price MO. Assessment of Corneal Crosslinking for the Treatment of Corneal Neovascularization With and Without Associated Infection. Cornea. 2025 Apr 2. doi: 10.1097/ICO.0000000000003869. Online ahead of print.

  PMID: 40172865 DERIVED

MeSH Terms

Conditions

Corneal Neovascularization

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis W Price, Jr., MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Price, PhD

CONTACT

317-814-2990; mprice@cornea.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: May 3, 2021
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)