Corneal Crosslinking for Treatment of Corneal Neovascularization

ConditionCorneal Neovascularization

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorPrice Vision Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

30 minute photoactivation of riboflavin 0.1%
Combination product
Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes
10 minute photoactivation of riboflavin 0.1%
Combination product
Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes

Treatment groups

138 Participants

are divided into 2 treatment groups

Group A: 30 minute photoactivationActive comparator 1 intervention

Group B: 10 minute photoactivationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Price Vision Group

Lead sponsor

Cornea Research Foundation of America

Collaborator

Source ClinicalTrials.gov

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