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Photo-activation of Riboflavin
Corneal Crosslinking for Corneal Neovascularization
Phase 2 & 3
Recruiting
Led By Francis W Price, Jr., MD
Research Sponsored by Price Vision Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test if a light-activated vitamin can safely and effectively treat an eye condition that causes new blood vessels to grow.
Who is the study for?
This trial is for adults over 18 with corneal neovascularization, which can cause vision problems due to abnormal blood vessels in the eye. It's open to those who haven't responded well to steroid treatments or are at risk of cornea transplant rejection. Pregnant individuals, those planning pregnancy, lactating, or with known sensitivity to treatment drugs cannot participate.Check my eligibility
What is being tested?
The study tests two durations of photoactivation (light exposure) of riboflavin (vitamin B2) on the eye: one lasting 30 minutes and another lasting 10 minutes. The goal is to see how safe and effective this treatment is for reducing unwanted blood vessel growth in the cornea.See study design
What are the potential side effects?
Potential side effects may include discomfort during light exposure, temporary visual disturbances, irritation or inflammation of the eye. Since it involves vitamin B2 and light therapy rather than traditional drugs, fewer systemic side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye has severe inflammation or infection affecting the cornea.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
corneal neovascularization as a proportion of the total corneal area
Trial Design
2Treatment groups
Active Control
Group I: 30 minute photoactivationActive Control1 Intervention
photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes
Group II: 10 minute photoactivationActive Control1 Intervention
photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes
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Who is running the clinical trial?
Price Vision GroupLead Sponsor
11 Previous Clinical Trials
1,621 Total Patients Enrolled
Cornea Research Foundation of AmericaOTHER
7 Previous Clinical Trials
2,957 Total Patients Enrolled
Francis W Price, Jr., MDPrincipal InvestigatorPrice Vision Group
5 Previous Clinical Trials
3,386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye has severe inflammation or infection affecting the cornea.You have had an allergic reaction to the medication being used in the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 30 minute photoactivation
- Group 2: 10 minute photoactivation
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does 30 minute photoactivation therapy usually target?
"30 minute photoactivation can be used for a variety of conditions, such as vitamin deficiency, joint pain, and vitamin supplementation."
Answered by AI
Are there any other research studies that use 30 minute photoactivation?
"As of now, there are 20 trials being run studying 30 minute photoactivation. 11 of those active studies are in Phase 3. While the majority of studies for 30 minute photoactivation are based in San Francisco, California, there are 47 locations running trials for this treatment."
Answered by AI
How many participants will be taking part in this experiment?
"That is correct. The listing on clinicaltrials.gov makes it clear that this study is still recruiting patients. The trial was first announced on May 3rd, 2021 and was last updated on July 27th, 2022. Currently, the research team is looking for 62 individuals from a single site."
Answered by AI
Are new participants being taken in for this experiment?
"That is correct, the listing on clinicaltrials.gov currently says that this study is open for recruitment. This specific trial was first announced on May 3rd, 2021 and was last updated on July 27th, 2022. They are 62 patients needed in total from 1 site."
Answered by AI
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