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Corneal Crosslinking for Treatment of Corneal Neovascularization

Primary Purpose

Corneal Neovascularization

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

30 minute photoactivation of riboflavin 0.1%

10 minute photoactivation of riboflavin 0.1%

About this trial

This is an interventional treatment trial for Corneal Neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Price Vision GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

30 minute photoactivation

10 minute photoactivation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04787471

First Posted

March 3, 2021

Last Updated

January 6, 2023

Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

1. Study Identification

Unique Protocol Identification Number

NCT04787471

Brief Title

Corneal Crosslinking for Treatment of Corneal Neovascularization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

April 15, 2025 (Anticipated)

Study Completion Date

July 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

30 minute photoactivation

Arm Type

Active Comparator

Arm Description

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

Arm Title

10 minute photoactivation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

30 minute photoactivation of riboflavin 0.1%

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

10 minute photoactivation of riboflavin 0.1%

Intervention Description

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

Primary Outcome Measure Information:

Title

corneal neovascularization as a proportion of the total corneal area

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne Price, PhD

Phone

317-814-2990

mprice@cornea.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis W Price, Jr., MD

Organizational Affiliation

Price Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne Price, PhD

Phone

317-814-2990

mprice@cornea.org

First Name & Middle Initial & Last Name & Degree

Francis Price, Jr., MD

First Name & Middle Initial & Last Name & Degree

Matthew Feng, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28655538

Citation

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.

Results Reference

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PubMed Identifier

28495149

Citation

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. Erratum In: Ophthalmology. 2017 Dec;124(12 ):1878.

Results Reference

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PubMed Identifier

29203068

Citation

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.

Results Reference

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PubMed Identifier

23062001

Citation

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.

Results Reference

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PubMed Identifier

33395116

Citation

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.

Results Reference

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Corneal Crosslinking for Treatment of Corneal Neovascularization

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