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Protein
ANXV for Retinal Vein Occlusion
Phase 2
Waitlist Available
Research Sponsored by Annexin Pharmaceuticals AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment for Retinal Vein Occlusion in patients; safety and effectiveness will be evaluated.
Who is the study for?
This trial is for adults over 18 with recent Retinal Vein Occlusion symptoms. Participants must be able to give informed consent, have certain vision acuity levels, and not be pregnant or breastfeeding. Men and women must use effective contraception. Exclusions include obesity (BMI ≥30), history of thrombosis, drug/alcohol abuse, uncontrolled hypertension, malignancy within 5 years (except treated skin cancers), current anticoagulant or benzodiazepine use, certain eye conditions/surgeries/injections in the past 6 months.
What is being tested?
The study tests ANXV (human recombinant Annexin A5) for safety and effectiveness in treating Retinal Vein Occlusion. It's an open-label trial where all participants receive the drug; doses increase as the study progresses to assess tolerance and potential benefits.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include allergic reactions to the medication components or infusion-related responses such as rash or breathing difficulties. As a safety study, part of its purpose is to identify any adverse effects from ANXV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety - Anti-drug antibodies
Safety - Treatment Emergent Adverse Events
Secondary study objectives
Efficacy - BCVA Improvement
Efficacy - BCVA Improvement or letter score ≥78
Efficacy - Microperimetry Change from baseline
+24 moreOther study objectives
ANXV binding sites
Endogenous Annexin A5
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: 8 mg ANXVExperimental Treatment1 Intervention
ANXV (human recombinant Annexin A5), infusion, 8 mg daily during five days.
Group II: 6 mg ANXVExperimental Treatment1 Intervention
ANXV (human recombinant Annexin A5), infusion, 6 mg daily during five days.
Group III: 4 mg ANXVExperimental Treatment1 Intervention
ANXV (human recombinant Annexin A5), infusion, 4 mg daily during five days.
Group IV: 2 mg ANXVExperimental Treatment1 Intervention
ANXV (human recombinant Annexin A5), infusion, 2 mg daily during five days.
Group V: 1 mg ANXVExperimental Treatment1 Intervention
ANXV (human recombinant Annexin A5), infusion, 1 mg daily during five days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANXV
2020
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Annexin Pharmaceuticals ABLead Sponsor
1 Previous Clinical Trials
46 Total Patients Enrolled
InFocus Clinical ResearchIndustry Sponsor
Anna FrostegårdStudy DirectorAnnexin Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 2 mg ANXV
- Group 2: 4 mg ANXV
- Group 3: 8 mg ANXV
- Group 4: 1 mg ANXV
- Group 5: 6 mg ANXV
Awards:
This trial has 1 awards, including:- 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.
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