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8 mg ANXV for Retinal Vein Occlusion
Study Summary
This trial tests a new treatment for Retinal Vein Occlusion in patients; safety and effectiveness will be evaluated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any eye conditions that could affect the study's results.I have had infections needing treatment with antivirals or antibiotics.I have tested positive for HIV, hepatitis C, or chronic hepatitis B.I have not had laser eye treatment in the past 6 months.I have not had eye surgery or eye injections in the last 6 months.I use benzodiazepines every day.I am not pregnant or breastfeeding, and I cannot have children due to surgery or menopause.I am 18 years old or older.I have a significant health condition.My kidney function is not normal.I am currently taking blood thinner medication.I have had serious bleeding issues in the past.I have not had any surgery or been in an accident in the last 4 weeks.I have glaucoma or my eye pressure is above 24 mmHg and not controlled.I have had blood clots or deep vein thrombosis in the last 6 months.I have been treated with a drug called recombinant Annexin A5 before.I started having vision problems due to a blocked vein in my eye less than 14 days ago.I have a genetic blood disorder.My eye's inner parts are clear and can be well-dilated for detailed imaging.My high blood pressure is not under control.I have had herpes infections in my eyes before.I haven't taken any medication harmful to my eyes in the last 6 months.I have used drugs to stop new blood vessels from forming or steroids.I am willing and able to attend all study visits and perform required tests.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.I am a male who is either sterile, abstinent, or using effective birth control if sexually active.I have had heart disease or a stroke in the past 6 months.
- Group 1: 8 mg ANXV
- Group 2: 2 mg ANXV
- Group 3: 1 mg ANXV
- Group 4: 4 mg ANXV
- Group 5: 6 mg ANXV
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants have been enrolled in the experiment thus far?
"The research study necessitates 28 qualifying participants, which Annexin Pharmaceuticals AB will source from Retina Consultants of Texas in Bellaire and Tulsa Retina Consultants."
Is recruitment still open for this clinical experiment?
"Clinicaltrials.gov indicates that this trial is currently recruiting, with the initial posting on August 24th and last review occurring October 10th of 2022."
Has 2 mg ANXV been granted official authorization by the FDA?
"Our team at Power judged the safety of 2 mg ANXV - active to be a level 2, as there is existing evidence in support of its security but none proving efficacy."
What is the current number of medical institutions that have this study in progress?
"The current trial is recruiting patients from 5 sites, including Retina Consultants of Texas in Bellaire and Tulsa Retina Consultants in San Antonio. Additionally, Valley Retina Institute in Tulsa along with three additional medical centres are hosting this clinical study."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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