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Tests treatment safety and results for Non-Proliferative Diabetic Retinopathy
Official title Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
ClinicalTrials.gov ID: NCT07259928
What this study is testing
What is ANXV?
ANXV is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for non-proliferative diabetic retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about the safety of the investigational medicinal product ANXV. It will also learn about how ANXV works to treat non-proliferative diabetic retinopathy and retinal vein occlusion in adults.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible to participate in this trial, an individual must meet all the following criteria:
- Must have given written informed consent (signed and dated), and any authorizations required by local law and be able to comply with all study...
- Male or female, ≥18 years of age at the time of informed consent
- Females should have no childbearing potential according to Clinical Trial Facilitation Group (CTFG) definition.
- Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this trial: General:
- Unwillingness or inability to attend all study visits and/or perform all procedures/tests/examinations, including follow-up, as specified by this...
- Any major medical or surgical procedure or trauma within 4 weeks prior to the day of trial intervention Treatment 1 (ANXV administration), or planned...
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because...
- Prior exposure to a recombinant Annexin A5 protein
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to...
See the full eligibility criteria
Who can join
- To be eligible to participate in this trial, an individual must meet all the following criteria:
- Must have given written informed consent (signed and dated), and any authorizations required by local law and be able to comply with all study requirements
- Male or female, ≥18 years of age at the time of informed consent
- Females should have no childbearing potential according to Clinical Trial Facilitation Group (CTFG) definition.
- Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging
- Willing to refrain from unusually strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 72 hours prior to study visits Additionally, NPDR participants must...
- Diagnosed with moderately severe or severe non-proliferative Diabetic Retinopathy defined as having a DRSS score of 47 and 53 respectively, and no CI-DMO
- Found to have an ETDRS BCVA score in the study eye (SE) of ≥69 ETDRS (equivalent to Snellen 6/12 or 20/40) Additionally, RVO participants must meet the following criteria to be eligible:
- Diagnosed with Retinal Vein Occlusion with onset of symptoms within 28 days prior to first administration of ANXV
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this trial: General:
- Unwillingness or inability to attend all study visits and/or perform all procedures/tests/examinations, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- Any major medical or surgical procedure or trauma within 4 weeks prior to the day of trial intervention Treatment 1 (ANXV administration), or planned major surgery within the duration of the study through Day 120
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the...
- Prior exposure to a recombinant Annexin A5 protein
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologics (for example systemically administered recombinant...
- Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 110 mmHg)
- Current use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) or corticosteroids
- Diagnosed untreated systemic metastasis malignancy
- A current systemic infection or inflammation that may require antiviral or antimicrobial therapy that will not be completed prior to Screening Visit, or that in the opinion of the Investigator and with concurrence of...
- Treatment with another investigational drug, biological agent, or device within 3 months of Screening Visit, or 5 half-lives of investigational agent, whichever is longer or planned participation in an treatment trial...
- History of thromboembolic events or deep venous thrombosis within 3 months of Screening Visit
- Current use of anticoagulant medication (any medications that might have effect on coagulation, haemostasis, and platelets); low dose aspirin allowed prior to informed consent but must be stopped at the time of consent...
- Current daily use of benzodiazepines
- Clinically significant abnormal coagulation parameters at baseline
- History of autoimmune disease with anticipated presence of persistent Annexin A5 antibodies, e.g., antiphospholipid syndrome, systemic lupus erythematosus, rheumatoid arthritis, Behcet disease or systemic sclerosis
- Inherited blood disorder (e.g. sickle cell disease, thalassemia)
- History of unstable coronary artery disease or cerebrovascular accident within the last 3 months
- Current known kidney disease or evidence of kidney disease and eGFR below 60 mL/min/1.73m2 at baseline
- Current drug or alcohol abuse as per the opinion of the Investigator, or current excessive nicotine intake (e.g. ≥ 20 cigarettes/day, or equivalent, as per the opinion of the Investigator)
- Known history of or positive test for chronic infection that affect the immune system (e.g. hepatitis C (HCV), chronic hepatitis B (HBV) and HIV)
- Class III obesity (Body Mass Index ≥ 40kg/m2), at the time of informed consent
- Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and...
- Known hypersensitivity or allergy to fluorescein (e.g., bronchospasm, rash, etc.) or to any component of the study products or a contraindication to dilation of the pupil or fixed pupils; mild allergies without...
- A severe (≥0.9 log, Grade 3+ or worse) Relative Afferent Pupillary Defect (RAPD)
- An IOP greater than 24 mmHg that is not controlled with medication or surgery at the time of the Screening Visit
- Recent (6 months) history of, or presence of uveitis, presence of intraocular inflammation (history of blepharitis is not exclusionary), current ocular infection
- Evidence of neovascularization
- ETDRS BCVA score in the Fellow eye of ≤54 (equivalent to Snellen 6/24 or 20/80)
- Ocular disorders/additional eye disease, which in the opinion of the Investigator may confound interpretation of study results, compromise protocol assessments or are likely to require intervention during the study...
- Receipt within the past 6 months or ongoing intravitreal injection of anti-VEGF treatment in either eye Study Eye only:
- Evidence of deep intraretinal haemorrhage involving the centre 1mm of the macula
- Laser photocoagulation in the study eye within the preceding 6 months prior to the Screening Visit, or likely to receive during the study period
- Intraocular surgery (including refractive surgery, cataract surgery), or intravitreal (IVT) injection within the preceding 6 months prior to the Screening Visit, or cataract surgery within the preceding 3 months prior...
- Recent (6 months) history, or current evidence of ocular herpetic diseases (including herpes simplex virus, varicella zoster or cytomegalovirus) NPDR participants will not be eligible if they meet any of the following...
- CI-DMO in either eye which, in the opinion of the Investigator, qualifies for anti-VEGF or laser treatment
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.