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Protein

8 mg ANXV for Retinal Vein Occlusion

Phase 2
Recruiting
Research Sponsored by Annexin Pharmaceuticals AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging
Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eye's inner parts are clear and can be well-dilated for detailed imaging.
Select...
I am not pregnant or breastfeeding, and I cannot have children due to surgery or menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety - Anti-drug antibodies
Safety - Treatment Emergent Adverse Events
Secondary outcome measures
Efficacy - BCVA Improvement
Efficacy - BCVA Improvement or letter score ≥78
Efficacy - Microperimetry Change from baseline
+25 more
Other outcome measures
ANXV binding sites
Endogenous Annexin A5

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

ANXV (Protein) Clinical Trial Eligibility Overview. Trial Name: NCT05532735 — Phase 2
Retinal Vein Occlusion Research Study Groups: 8 mg ANXV, 2 mg ANXV, 1 mg ANXV, 4 mg ANXV, 6 mg ANXV
Retinal Vein Occlusion Clinical Trial 2023: ANXV Highlights & Side Effects. Trial Name: NCT05532735 — Phase 2
ANXV (Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05532735 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Tulsa Retina Consultants
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jun 2024