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Status unknownNCT03725566Updated Oct 31, 2018

JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients

An interventional study of Experimental in Macular Degeneration, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2018, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Ages
50 Years to 75 Years
Sex
All
01

Study summary

Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration

Read the detailed description

Test drug:Recombinant humanized anti VEGF monoclonal antibody injection; Research Phase:Phase I; Subjects:Subjects with neovascular (wet) age-related macular degeneration; Number of Subjects:24; Trial design:Single center, non randomized, open, single arm, single dose, dose escalation; Research objective:to rearch the safety and tolerance of JY028 injection;to rearch PK of JY028 injection;to observe the efficacy of JY028 in the treatment of nAMD;to rearch the relationship between plasma VEGF concentration and JY028 concentration. to rearch immunogenicity of JY028;

02

Conditions studied

  • Macular Degeneration

Keywords

  • New vascular macular degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 24 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patient volunteered to participate and signed the informed consent 2. No more than 50 years of age and less than 75 years of age, male or female 3. Diagnosed as nAMD 4. The optimal corrected visual acuity of the target eye ETDRS should be no more than 50 letters, and the optimal corrected visual acuity of the opposite eye should be no more than 34 letters 5. The target eye pressure is no more than 25mmHg, which can be controlled by drugs 6. A normal coagulation function: the platelet count is 100 x 10 \^ 9-300x 10\^10 / L, thrombin time, prothrombin time within the normal range.

Exclusion criteria

-

Exclusion Criteria:

  1. Choroid polypoid angiopathy (PCV)
  2. There are other obvious eye diseases/conditions (such as diabetic retinopathy, cataract, abnormal eyelid, uncontrolled glaucoma, eye active inflammation, etc.)
  3. CNV caused by other causes other than nAMD, such as diabetic retinopathy, vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc
  4. The target eye has received any intraocular surgery or laser therapy within 3 months prior to enrollment
  5. Any eye treated with antiangiogenic drugs within 3 months prior to baseline visit
  6. Patients with active eye infections, such as conjunctivitis, keratitis, sclerotic, blepharitis, endophthalmitis or uveitis
  7. Persons with a history of myocardial infarction and/or cerebral infarction or other active or acute cardiovascular diseases
  8. HIV antibody/hiv-p24 antigen, any of the positive subjects in the treponema pallidum antibody
  9. Active HBsAg carriers (conditions must be met: HBsAg positive, HBV DNA positive, ALT higher than normal upper limit)
  10. Patients with HCV (the following conditions must be met: lgM positive anti-hcv antibody, ALT higher than the upper limit of normal value)
  11. Fluorescein sodium allergy
  12. Allergy to anti-vegf monoclonal antibodies or humanized monoclonal antibodies
  13. Patients who participated in other clinical trials within 3 months
  14. Patients who took NSAIDs and aspirin or other anticoagulant or platelet drugs within 1 month before enrollment
  15. An unhealed wound, ulcer, fracture, or other related medical condition
  16. Patients with uncontrollable hypertension, with systolic blood pressure of > 140mmHg and diastolic blood pressure of > 90mmHg
  17. Patients with uncontrollable clinical diseases or problems (such as serious mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors)
  18. Pregnant and lactating women and those who cannot take contraceptive measures
  19. According to the researcher, it is not suitable for the candidate -
05

Study design

Phase
Not applicable
Primary purpose
Other
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Experimental

    Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;

    Drug: Experimental

Interventions

  • DrugExperimental

    Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;

    Also known as: intravitreous injection

06

What researchers measure

Primary outcomes

  1. JY028 related incidence of ocular and systemic adverse events and serious adverse events

    JY028 related incidence of ocular and systemic adverse events and serious adverse events

    Time frame: 13 weeks

Secondary outcomes

  1. Cmax

    Maximum blood drug concentration

    Time frame: 13 weeks

  2. Tmax

    Peak time of blood drug concentration

    Time frame: 13 weeks

  3. BCVA

    The best corrected visual acuity change

    Time frame: 13 weeks

  4. AUC0-t、AUCinf

    The area under the plasma concentration time curves

    Time frame: 13 weeks

07

Study locations

1 site
  • Beijing Tongren Hospital
    Beijing, Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03725566
Lead sponsor
Beijing Tongren Hospital
Responsible party
Sponsor
First posted
Oct 31, 2018
Start date
May 22, 2018
Primary completion
May 1, 2020 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Oct 31, 2018

Study contacts

xiu li zhao, doctor
principal investigator · Beijing Tongren Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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