- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151407
The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)
A Phase I , Multicenter, Open-Label, Single/Multiple Dose- Escalation Study of Recombinant Humanized Anti-VEGF Monoclonal Antibody Injection in Patients With Diabetic Macular Edema(DME)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiaodong Sun, PhD
- Phone Number: +86-021-36216424
- Email: xdsun@sjtu.edu.cn
Study Contact Backup
- Name: Fenghua Wang, Doctor
- Phone Number: +86-021-36216424
- Email: smilefh@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Chinese PLA General Hospital of Central Theater.
-
Principal Investigator:
- Yanping Song
-
Contact:
- YanPing Song, PhD
-
Contact:
- Ya Ye, Doctor
- Phone Number: +86-027-50772574
- Email: 470902810@qq.com
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- Jiangsu Province Hospital
-
Contact:
- Huai Qing Liu, PhD
-
Contact:
- SongTao Yuan, Doctor
- Phone Number: +86-025-83718836-3638
- Email: yuansongtao@vip.sina.com
-
Principal Investigator:
- QingHuai Liu
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Shanghai General Hospital
-
Contact:
- Fenghua Wang, Doctor
- Phone Number: +86-021-36216424
- Email: smilefh@126.com
-
Contact:
- Xiaodong Sun, PHD
-
Principal Investigator:
- Xiaodong Sun, PhD
-
-
Sichuan
-
ChengDu, Sichuan, China, 610000
- Recruiting
- West China Hospital of Sichuan University
-
Contact:
- Ming Zhang, PhD
-
Contact:
- Fang Lu, Doctor
- Phone Number: +86-028-85422452
- Email: lufang@medicail.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sign informed consent form and willing to be visited at the time specified in the trial
- Age >= 18 years and age =< 75 years
- Diagnosis of type 1 or type 2 diabetes
- Hemoglobin (HbA1c) value =< 11%
The study eye must meet the following criteria
- Diabetic macular edema with central fovea involvement and visual impairment in subjects;
- Best corrected visual acuity letter score (ETDRS)>= 19 (i.e., 20/400 or better) and <= 73 (i.e., 20/40 or worse)in the study eye;
- CRT ≥ 275 μm;
- No optometric media opacity and pupil shrinkage.
- Best corrected visual acuity letter score (ETDRS) > =24 (i.e., 20/320 or better)in the fellow eyes
Exclusion Criteria:
- Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis);
- The study eye has proliferative diabetic retinopathy (PDR), except for the PDR with regression after panretinal photocoagulation, and Inactive, fibrotic PDR
- History of vitreous hemorrhage in the study eye within 2 months before screening
- Structural retinal damage with fovea in the study eye (e.g. retinal pigment epithelium(RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudation), or researchers believe that the study eye has other retinal damage that may hinder visual improvement after macular edema subsides
- In addition to diabetic retinopathy, there are other causes of macular edema or visual changes in the study eye.
Ophthalmic conditions (e.g.,retinal vein occlusion (RVO) Choroidal neovascularization, retinal detachment, macular hole, retinal traction in macular region, epiretinal membrane, etc.)
- Iris neovascularization in the study eye;
- Uncontrollable glaucoma in the study eye (defined as intraocular pressure after antiglaucoma medication>= 25 mm Hg), or glaucoma filtering surgery history;
- Researchers believe that cataract in the study eye may affect the judgement of examination or test results, or surgical treatment is required in 6 months following screening
- The study eye has no lens( except intraocular lens)
- History of Intraocular injection for corticosteroids (e.g. triamcinolone) at any time in the past 3 months, or corticosteroids injection around the eyes within one month before screening
- History of vitrectomy in the studyeye
- History of panretinal photocoagulation in the study eye in the past 6 months before screening; or panretinal photocoagulation may be required following screening
- Study eye have received more than two local/grid retinal photocoagulation treatments, or history of local/grid retinal photocoagulation treatments in the study eye in the past 3 months before screening
- History of anti-VEGF drugs treatments(e.g. Abercept, Pigatani Sodium, Razumab, Bevacizumab, etc.) in any eye or system within 3 months before screening;
- History of any intraocular surgery (e.g. cataract surgery, YAG posterior capsulotomy, etc) in the study eye within 3 months before screening;
- History of ophthalmic surgery involving macular areas (e.g. PDT, macular transposition) in the study eye, except for local/grid retinal photocoagulation
Any of the following general condition are present:
- Uncontrolled blood pressure control (defined as systolic blood pressure > 150 mmHg or diastolic pressure > 95 mmHg after antihypertensive medication
- The subjects is suffering from systemic infections and requiring oral, intramuscular or intravenous medication
- History of stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure in the past 6 months before screening;
- Medicines with toxicity to the lens, retina or optic nerve (deferoxamine, chloroquine,hydroxychloroquine (chloroquine), tamoxifen and phenol etc.) is being used or may be used during the study period
- Diagnosed systemic immune diseases (e.g. ankylosing spondylitis and systemic lupus erythematosus etc.), or any uncontrolled clinical problem (e.g. AIDS, malignant tumors, active hepatitis, serious mental, neurological, cardiovascular, respiratory and other systemic diseases, etc.)
- History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis, history of allergy to more than two drugs and/or non-drug factors, or suffering from allergic diseases now
Any of the following laboratory tests abnormalities:
- Diabetic patients with uncontrolled blood glucose (fasting blood glucose >= 8.8 mmol/L);
- Renal function impairment (Cr is 1.5 times higher than the upper limit of normal values in the local laboratory) Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal value in the local laboratory).
- Abnormal coagulation function (prothrombin time >= the upper limit of normal value for 3 seconds) and activated partial thromboplastin time >= the upper limit of normal value for 10 seconds)
Patients with childbearing age with any of the following conditions:
- Those who do not use effective contraceptive measures;
The following are not excluded:
- Natural amenorrhea for more than 12 months, or natural amenorrhea for 6 months and the serum follicle-stimulating hormone level > 40 mIU/mL;
- Bilateral ovariectomy with/without hysterectomy for more than 6 weeks;
- Use acceptable contraceptive methods(Sterilization, hormone contraception,Intrauterine device, double barrier method)
Be able to use reliable contraceptives throughout the study period and stick to the end of the visit, (Unacceptable contraceptive methods include regular abstinence by calendar, ovulation, body temperature measurement, post-ovulation and fertilization in vitro);
- Pregnancy and lactation women (pregnancy is defined as urinary pregnancy test positive in this study)
- Participation in any other drug clinical trials (except vitamins and minerals) in the past 1 month before screening
- Researchers think it needs to be ruled out.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 601 dose level 1 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg),
Vitreous injection, injection once;
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 2 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg),
Vitreous injection, injection once
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 3 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg),
Vitreous injection, injection once
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 4 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg),
Vitreous injection, injection once;
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 5 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(3.75mg),
Vitreous injection, injection once;
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 6 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg),
Vitreous injection, injection once every 4 weeks, three times continuously.
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
Experimental: 601 dose level 7 treatment
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg),
Vitreous injection, injection once every 4 weeks, three times continuously.
|
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLT
Time Frame: From Day 0 up to Day 28
|
Incidence of dose-limiting toxicities up to the Day 28
|
From Day 0 up to Day 28
|
MTD
Time Frame: From Day 0 up to Day 56/112.
|
Maximum tolerated dose
|
From Day 0 up to Day 56/112.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: From Day 0 up to 56/112 days
|
The maximum blood concentration after 601 drug enters the bloodstream
|
From Day 0 up to 56/112 days
|
t1/2
Time Frame: From Day 0 up to 56/112 days
|
The half-life of drug 601, the time required for the terminal phase 601 drug concentration to drop by half
|
From Day 0 up to 56/112 days
|
AUC
Time Frame: From Day 0 up to 56/112 days
|
Area under the concentration-time curve, reflect the characteristics of the exposure of 601 drug in the body.
|
From Day 0 up to 56/112 days
|
Vd
Time Frame: From Day 0 up to 56/112 days
|
The proportional constant between the amount of 601 drug in the body and the blood concentration when the 601 drug achieves the dynamic balance in the body
|
From Day 0 up to 56/112 days
|
CL
Time Frame: From Day 0 up to 56/112 days
|
Clearance rate of drug 601 from the central ventricle.
|
From Day 0 up to 56/112 days
|
MRT
Time Frame: From Day 0 up to 56/112 days
|
The average length of time that the 601 drug stays in the body.
|
From Day 0 up to 56/112 days
|
λz
Time Frame: From Day 0 up to 56/112 days
|
the ratio of the amount of elimination of 601 drug from the body per unit time to the total amount in the body
|
From Day 0 up to 56/112 days
|
Biomarker
Time Frame: From Day 0 up to 56/112 days
|
Detection of VEGF concentration
|
From Day 0 up to 56/112 days
|
Immunogenicity
Time Frame: From Day 0 up to 56/112 days
|
Development of Anti-drug antibodies (ADA) after IVT injection of 601
|
From Day 0 up to 56/112 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSGJ-601-DME-I-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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