AzTrials
AzTrials

Neovascular Age-Related Macular DegenerationPhase 1NCT03387566

A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration

A Phase 1 study testing HB002.1M in people with Neovascular Age-Related Macular Degeneration, run by Huabo Biopharm Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with age-related macular degeneration (AMD). Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
HB002.1M
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
8 Feb 2018to 23 Mar 2020
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent
  • Age 50 to 80 years old of either gender
  • Study eye must meet following requirements:
  • Active CNV lesions secondary to AMD
  • A lesion area <30 mm2 (12 disc areas) of any lesion type
  • BCVA ranging from 73-19 letters (20/32-20/400 Snellen equivalent), inclusive
  • Clear ocular media and adequate pupil dilation to permit good quality photographic imaging
  • Fellow eye must have had BCVA of 19 letters ( 20/400 Snellen equivalent) or better

Who cannot join

  • Any ophthalmic condition as below:
  • Presence of non-exudative AMD in the study eye as determined by investigator that affect macular examination, or presence of any diseases that affect central vision (including central retinal vein occlusion, diabetic retinopathy, uveitis, vascular fringes, pathological myopia, amotio retinae, macula hole etc.
  • Subretinal hemorrhage in the study eye the area of hemorrhage≥of total lesion area, or hemorrhage in central fovea≥1 disc area
  • Presence of scar, fibrosis or atrophy in central fovea of the study eye
  • CNV of the study eye associated with other ocular conditions , such as pathologic myopia, ocular histoplasmosis, posterior uveitis, or trauma
  • Anatomic damage to the center of the fovea including fibrosis and scarring making up >50% of total lesion area including the CNV in the study eye
Show all 34Show fewer
  • History or presence of a retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole in the study eye
  • History of study eye with intraocular or any ophthalmic surgery within prior 3 months (including Laser Photocoagulation at the para fovea , cataract etc.)
  • History of study eye with photodynamic therapy, macular translocation surgery trabeculectomy, Recess photocoagulation, thermal laser or external beam radiation in the study eye
  • History within 6 months of screening of following treatments(such as Macugen, Lucentis, Avastin, Eylea, Conbercpet, steroids etc)
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure of >25 mmHg despite treatment with maximal medical therapy)
  • History of any vitreous hemorrhage within 3 months
  • Any systemic conditions as below:
  • Currently or potentially using any drug that will cause ocular toxicity, such as psoralen, risedronic acid; or tamoxifen etc.
  • Allergic to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic to ≥ two drugs or non-drugs, or with current allergic disease
  • Uncontrolled diabetes mellitus (fast glucose level ≥7.0 mmol/L or ≥11.1 mmol/L 2h after meal)
  • History of surgery and/or unhealed wound, ulcer, fracture etc. 1 month prior to screening
  • Any infectious disease requiring oral, intramuscular or intravenous administrations
  • History of Myocardial infarction and cerebral infarction within 6 months of screening
  • Active diffuse intravascular coagulation 3 months prior to screening
  • Systemic immunological diseases
  • Uncontrolled hypertension ≥150 mmHg systolic or ≥95 mmHg diastolic at baseline
  • Any severe or uncontrolled medical conditions (eg, unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia)
  • Any abnormal laboratory results as below:
  • Abnormal liver or kidney function test value (glutamic-oxalacetic transaminase(AST), glutamic-pyruvic transaminase(ALT), creatinine(Crea), blood urea nitrogen(BUN) that was more than 1.2 times of the upper limit of normal value)
  • Abnormal coagulation test(≥3 sec of upper limit value of prothrombin time, ≥10 sec of upper limit value of activated partial thromboplastin time(APTT))
  • Positive in HbsAg, hepatitis C virus(HCV) antibody, human immunodeficiency virus(HIV) antibody and syphilis antibody
  • Other conditions related to subjects with women of childbearing potential:
  • Without using any contraceptive method
  • Pregnancy or lactation (urine pregnancy test positive)
  • Others:
  • Participated clinical studies using any medications (not including vitamins and minerals) 6 months prior to screening
  • Any assessment by the investigator to be unable to or unwilling to comply with requirements of the protocol

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: A Phase 1, Safety, Tolerability and Pharmacokinetic Profile Study of Intravitreous Injections of HB002.1M (a Vascular Endothelial Growth Factor Receptor Decoy) in Subjects With Neovascular Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with age-related macular degeneration (AMD).

Being tested
HB002.1M

What participants receive

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

  • HB002.1MDrug

    Also called Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection

    HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.

Study groups in NCT03387566
Study groupRoleWhat they receive
HB002.1M 0.3mgExperimentalParticipants received a 0.3mg dose of HB002.1M via intravitreal (IVT) injection.
Receives: Drug: HB002.1M
HB002.1M 0.5mgExperimentalParticipants received a 0.5mg dose of HB002.1M via intravitreal (IVT) injection.
Receives: Drug: HB002.1M
HB002.1M 1.0mgExperimentalParticipants received a 1.0mg dose of HB002.1M via intravitreal (IVT) injection.
Receives: Drug: HB002.1M
HB002.1M 2.0mgExperimentalParticipants received a 2.0mg dose of HB002.1M via intravitreal (IVT) injection.
Receives: Drug: HB002.1M
HB002.1M 3.0mgExperimentalParticipants received a 3.0mg dose of HB002.1M via intravitreal (IVT) injection.
Receives: Drug: HB002.1M

What is being measured

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

  1. Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)

    Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)

    Measured: Up to 1 month after the single dose

Secondary outcomes (8)

  1. T1/2 (Terminal phase half life) after single dose

    Measured: 1 months

  2. Cmax (maximum observed concentration) after single dose

    Measured: 1 months

  3. AUC (Area Under Concentration-Time Curve) after single dose

    Measured: 1 months

  4. Immunogenicity Evaluation after single dose

    Incidence of ADA(Anti-Drug Antibody) response

    Measured: 2 months

  5. Change in Best Corrected Visual Acuity (BCVA) from baseline

    Measured: 1 month

  6. Change in central retinal thickness from baseline by Optical Coherence Tomography (OCT)

    Measured: 1 month

  7. Change in Choroidal Neovascularization (CNV) lesion area from baseline according to fluorescein angiogram

    Measured: 1 month

  8. Change of VEGF(Vascular Endothelial Growth Factor A) from baseline

    Measured: 1 month

Timeline

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

  1. First posted2 Jan 2018
  2. Study start8 Feb 2018
  3. Primary completion1 Feb 2020
  4. Study completion23 Mar 2020

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
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387566
Sponsor's protocol ID
HB002.1M-01
Status last verified
Jul 2020
First submitted
11 Dec 2017
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HB002.1M in people with Neovascular Age-Related Macular Degeneration, run by Huabo Biopharm Co., Ltd. at 1 site in China.

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 8 inclusion and 34 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: finished, as of the sponsor's last update on 29 Jul 2020. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose) (time frame: Up to 1 month after the single dose). 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 NCT03387566.

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 29 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in