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Retinal Vein OcclusionPhase 1SIGHTNCT05133791

NIR Fluorescence Molecular Imaging of ANXV-800CW in RVO Patients

A Phase 1 study testing Annexin A5 in people with Retinal Vein Occlusion, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is safety, tolerability and feasibility of systemic intravenous injection of ANXV-800CW in patients with RVO in three dosing-cohorts in a phase I safety study. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Retinal Vein Occlusion
What is being tested?
Annexin A5
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
23 Sep 2021to 1 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to adhere to the prohibitions and restrictions specified in this protocol.
  • Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
  • Patients aged 18-85 years inclusive at moment signing informed consent form.
  • Established (sub) acute Retinal Vein Occlusion
  • o Branch retinal vein occlusion (BRVO) or Central retinal vein occlusion (CRVO)
  • BMI ≥ 18.0 and ≤ 30.0 kg/m2 and weight at least 50 kg and no more than 100 kg at screening.
Show all 14Show fewer
  • Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator.
  • o Note: one retest of vital functions and ECG is allowed within the screening window
  • No clinically significant laboratory abnormalities as determined by the investigator
  • o Note: one retest of lab tests is allowed within the screening window
  • Female patients should fulfil one of the following criteria:
  • At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >30 mIU/mL) at screening;
  • Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
  • Male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control, and must not donate sperm, until 3 months after administration of ANXV-800CW.

Who cannot join

  • General
  • Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the patient to understand and cooperate with the study protocol
  • Deprived of freedom by an administrative or court order or in an emergency setting.
  • Insufficient venous access for the study procedures.
  • Close affiliation with the investigator; e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of Ophthalmology of the UMCG, TRACER or affiliates
  • Plasma donation within one month of visit 1 or blood donation of >450 ml during the three months prior to visit 1
Show all 44Show fewer
  • Any finding in the medical examinations or medical history giving, in the opinion of the Investigator, reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
  • Participation in an interventional clinical study within 30 days prior to screening visit (visit 1) that involved treatment with any drug (excluding vitamins and minerals) or medical device
  • Current alcohol/illicit drug abuse or addiction: history or evidence of current drug use or addiction (positive urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or excessive use of alcohol at screening.
  • Positive blood for safety: positive blood test on Hepatitis B, Hepatitis C and HIV.
  • Medical conditions
  • Previous confirmed COVID19 disease requiring hospital care or positive COVID19 test at visit 1.
  • Eye disease that significantly interferes with fundus examinations in one or both eyes
  • Dilatation of the pupil < 5 mm in the study eye
  • Ocular inflammation (including trace or more severe) or conjunctivitis at screening, or history of uveitis in either eye
  • Only one functional eye
  • History of Thromboembolic events or deep venous thrombosis < 6 months of screening visit (visit 1)
  • Usage of anticoagulant medication (any form)
  • Usage of benzodiazepines
  • History of significant bleeding (gross haematuria, haemoptysis, gastrointestinal tract bleeding)
  • Evidence or history of a hypercoagulable state (e.g. shortened APTT).
  • Document history of autoimmune disease with anticipated presence of potentially pathogenic Annexin A5 antibodies, e.g. antiphospholipid syndrome, systemic lupus erythematosus or systemic sclerosis.
  • Confirmed thalassemia (e.g sickle cell disease)
  • Any history of coronary artery disease or cerebrovascular accident within the last 6 months.
  • Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60 mmHg
  • Uncontrolled arterial hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
  • Cardiac impairment with an estimated LVEF < 35 % Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator
  • History of or a currently active hepatic or biliary disease
  • History of or a currently active neurological disease
  • eGFR (based on plasma-creatinine) outside of normal range at screening or known renal impairment (≤70 mL/min).
  • Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
  • Current evidence or history of bacterial, viral or fungal infections within 7 days before ANXV-800CW administration as judged by the Investigator.
  • o T > = 38.0°C or lab confirmed viral/bacterial/fungal infection (PCR)) or symptoms suggestive of an infection)
  • Any planned major surgery within the duration of the study (until visit 3), with the exception of any emergency surgeries.
  • Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be clinically significant
  • A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angio-edema or treatment need can be acceptable if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)
  • A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive airway disease associated with exercise
  • Prior therapy
  • Any prior systemic anti-VEGF treatment or intravitreal (IVT) anti-VEGF treatment in the affected eye within a period of 3 months prior to start of the study
  • Any prior intraocular steroid injection in the affected eye within a period of 3 months prior to start of the study
  • Any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior panretinal photocoagulation (PRP) in the affected eye
  • Any intraocular eye surgery in the affected eye within a period of 3 months prior to start of the study
  • Yttrium-Aluminum-Garnet laser treatment performed within 28 days before screening, in the affected eye

Trial locations and contacts

1 site in 1 country.

Yester Janssen, MD contact

+31615170900

y.f.janssen@umcg.nl

Hendrikus Boersma, PharmD, PhD contact

h.h.boersma@umcg.nl

Netherlands1 site, 1 recruiting

  • UMCG

    Groningen, 9700RB

    Yester Janssen, MD, +31615170900, y.f.janssen@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Near-Infrared Fluorescence Molecular Imaging of ANXV-800CW to Visualize Its Biodistribution in the Eyes of Patients Suffering From Retinal Vein Occlusion

The primary objective is safety, tolerability and feasibility of systemic intravenous injection of ANXV-800CW in patients with RVO in three dosing-cohorts in a phase I safety study. Secondary objectives are to determine in the pre-mentioned dosing-cohorts the pharmacokinetic profile of ANXV-800CW and to determine phosphatidylserine availability as measured by flow cytometry in whole blood before and after ANXV-800CW administration.

Study design: non-randomized, non-blinded, prospective, mono-center safety/ feasibility dose optimization study

Read more

Study population: Patients referred for (sub-)acute blurred vision with the diagnosis of RVO aged 18-85 years, fertile females excluded.

Intervention: All patients will undergo a standard of care ophthalmological work-up to establish the diagnosis of RVO. In the context of this study, Fluoresceine Angiography (FA) will be added to the ophthalmological work-up for all patients. Furthermore, the patients will receive a systemic single-dose injection of ANXV-800CW as part of a optimization study, followed by NIR retinal fluorescence imaging.

Main study parameters/endpoints: The main study parameters studies are safety, tolerability and feasibility of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW.

Being tested
Annexin A5
Keywords
Near Infra red (NIR), Fluorescence molecular imaging, Annexin A5-800CW
Medical subject headings
Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Annexin A5Drug

    Also called Flurescein Angiography

    Annexin A5 coupled to IRDye800CW as a potential treatment for RVO

Study groups in NCT05133791
Study groupRoleWhat they receive
0.5 mgActive comparatorAnnexin A5-CW800, 0.5 mg, 1 dose
Receives: Drug: Annexin A5
1.0 mgActive comparatorAnnexin A5-CW800, 1.0 mg, 1 dose
Receives: Drug: Annexin A5
2.0 mgActive comparatorAnnexin A5-CW800, 2.0 mg, 1 dose
Receives: Drug: Annexin A5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW

    Safety will be assessed by looking at AEs,SAEs, and SUSARs as identified by a questionnaire, but also by looking at vital signs: blood pressure (mmHg), heart rate (beats per minute), temperature (degrees celsius) respiratory rate (breaths per minute)

    Measured: 1.5 years

  2. Tolerability of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW

    Tolerability will be assessed by looking at AEs,SAEs, and SUSARs as identified by a questionnaire, but also by looking at vital signs: blood pressure (mmHg), heart rate (beats per minute), temperature (degrees celsius) respiratory rate (breaths per minute)

    Measured: 1.5 years

  3. Feasibility of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW

    Fluorescence intensity (Arbitrary Units) will be measured by using the NIR imaging system and the target to background ratio (reported as the mean, SD, and range) will be calculated from fluorescence images

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start23 Sep 2021
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
non-randomized, non-blinded, prospective, mono-center safety/ feasibility dose optimization study
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133791
Sponsor's protocol ID
2021-000866-13
Acronym
SIGHT
Status last verified
Aug 2023
First submitted
16 Sep 2021
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Annexin A5 in people with Retinal Vein Occlusion, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yester Janssen, MD (+31615170900, y.f.janssen@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of near-infrared fluorescent imaging in the retina of patients with RVO related to the systemic injection of ANXV-800CW (time frame: 1.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05133791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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