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

Primary Purpose

Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Macular Degeneration focused on measuring New vascular macular degeneration

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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 -

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax
Maximum blood drug concentration
Tmax
Peak time of blood drug concentration
BCVA
The best corrected visual acuity change
AUC0-t、AUCinf
The area under the plasma concentration time curves

Full Information

First Posted
September 20, 2018
Last Updated
October 30, 2018
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03725566
Brief Title
JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients
Official Title
Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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
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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
New vascular macular degeneration

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
Intervention Type
Drug
Intervention Name(s)
Experimental
Other Intervention Name(s)
intravitreous injection
Intervention Description
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
Primary Outcome Measure Information:
Title
JY028 related incidence of ocular and systemic adverse events and serious adverse events
Description
JY028 related incidence of ocular and systemic adverse events and serious adverse events
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum blood drug concentration
Time Frame
13 weeks
Title
Tmax
Description
Peak time of blood drug concentration
Time Frame
13 weeks
Title
BCVA
Description
The best corrected visual acuity change
Time Frame
13 weeks
Title
AUC0-t、AUCinf
Description
The area under the plasma concentration time curves
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Choroid polypoid angiopathy (PCV) There are other obvious eye diseases/conditions (such as diabetic retinopathy, cataract, abnormal eyelid, uncontrolled glaucoma, eye active inflammation, etc.) CNV caused by other causes other than nAMD, such as diabetic retinopathy, vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc The target eye has received any intraocular surgery or laser therapy within 3 months prior to enrollment Any eye treated with antiangiogenic drugs within 3 months prior to baseline visit Patients with active eye infections, such as conjunctivitis, keratitis, sclerotic, blepharitis, endophthalmitis or uveitis Persons with a history of myocardial infarction and/or cerebral infarction or other active or acute cardiovascular diseases HIV antibody/hiv-p24 antigen, any of the positive subjects in the treponema pallidum antibody Active HBsAg carriers (conditions must be met: HBsAg positive, HBV DNA positive, ALT higher than normal upper limit) Patients with HCV (the following conditions must be met: lgM positive anti-hcv antibody, ALT higher than the upper limit of normal value) Fluorescein sodium allergy Allergy to anti-vegf monoclonal antibodies or humanized monoclonal antibodies Patients who participated in other clinical trials within 3 months Patients who took NSAIDs and aspirin or other anticoagulant or platelet drugs within 1 month before enrollment An unhealed wound, ulcer, fracture, or other related medical condition Patients with uncontrollable hypertension, with systolic blood pressure of > 140mmHg and diastolic blood pressure of > 90mmHg Patients with uncontrollable clinical diseases or problems (such as serious mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors) Pregnant and lactating women and those who cannot take contraceptive measures According to the researcher, it is not suitable for the candidate -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiu li zhao, doctor
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

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

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