Corneal NeovascularizationPhase 2/3NCT04787471
Corneal Crosslinking for Treatment of Corneal Neovascularization
A Phase 2/3 study testing 30 minute photoactivation of riboflavin 0.1% and 10 minute photoactivation of riboflavin 0.1% in people with Corneal Neovascularization, run by Price Vision Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- 30 minute photoactivation of riboflavin 0.1% and 10 minute photoactivation of riboflavin 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 15 Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
Marianne Price, PhD, 317-814-2990, mprice@cornea.org
Francis Price, Jr., MD
About this study
Official title: Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
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
- Being tested
- 30 minute photoactivation of riboflavin 0.1%, 10 minute photoactivation of riboflavin 0.1%
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 30 minute photoactivation | Active comparator | photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes Receives: 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 Receives: Combination Product: 10 minute photoactivation of riboflavin 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start3 May 2021
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Corneal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cornea Research Foundation of America
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr., MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787471
- Sponsor's protocol ID
- 2021-001
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28655538Hersh 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.
PubMed 28495149Price 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.
PubMed 29203068Price 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.
PubMed 23062001Schaub 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.
PubMed 33395116Price 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. 2026 Apr 1;45(4):450-456. doi: 10.1097/ICO.0000000000003869. Epub 2025 Apr 2.
PubMed 40172865
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
- ClinicalTrials.gov ID
- NCT04787471
- Acronym / sponsor ID
- 2021-001
- Conditions
- Corneal Neovascularization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Collaborators
- Cornea Research Foundation of America
- Study start
- 3 May 2021 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 minute photoactivation | Active comparator | Combination Product: 30 minute photoactivation of riboflavin 0.1%photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes |
| 10 minute photoactivation | Active comparator | Combination Product: 10 minute photoactivation of riboflavin 0.1%photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 minute photoactivation of riboflavin 0.1%Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes | Combination product | 30 minute photoactivation |
| 10 minute photoactivation of riboflavin 0.1%Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes | Combination product | 10 minute photoactivation |
Primary outcome
corneal neovascularization as a proportion of the total corneal area
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 28655538Hersh 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.
- Background: PubMed 28495149Hersh 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.
- Background: PubMed 29203068Price 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.
- Background: PubMed 23062001Price 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.
- Background: PubMed 33395116Schaub 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.
- Derived from this study: PubMed 40172865Price 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. 2026 Apr 1;45(4):450-456. doi: 10.1097/ICO.0000000000003869. Epub 2025 Apr 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis W Price, Jr., MD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 30 minute photoactivation of riboflavin 0.1% and 10 minute photoactivation of riboflavin 0.1% in people with Corneal Neovascularization, run by Price Vision Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Price, PhD (317-814-2990, mprice@cornea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal neovascularization as a proportion of the total corneal area (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787471, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.