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Corneal Crosslinking for Treatment of Corneal Neovascularization

Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04787471
Enrollment
138
Registered
2021-03-08
Start date
2021-05-03
Completion date
2029-09-15
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Neovascularization

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.

Interventions

COMBINATION_PRODUCT30 minute photoactivation of riboflavin 0.1%

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

COMBINATION_PRODUCT10 minute photoactivation of riboflavin 0.1%

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

Sponsors

Price Vision Group
Lead SponsorINDUSTRY
Cornea Research Foundation of America
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
corneal neovascularization as a proportion of the total corneal area6 monthsthe 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.

Countries

United States

Contacts

CONTACTMarianne Price, PhD
mprice@cornea.org317-814-2990
PRINCIPAL_INVESTIGATORFrancis W Price, Jr., MD

Price Vision Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026