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Diabetic Macular EdemaPhase 1NCT04151407

The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)

A Phase 1 study testing Drug 601 in people with Diabetic Macular Edema, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Drug 601
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesChina
Study dates
8 Mar 2019to Dec 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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

Who cannot join

  • 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.)
Show all 38Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Xiaodong Sun, PhD contact

+86-021-36216424

xdsun@sjtu.edu.cn

Fenghua Wang, Doctor contact

+86-021-36216424

smilefh@126.com

China4 sites, 4 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Ming Zhang, PhD

    Fang Lu, Doctor, +86-028-85422452, lufang@medicail.com.cn

    Recruiting

  • JiangSu Province Hospital

    Nanjing, Jiangsu, 210029

    Huai Qing Liu, PhD

    SongTao Yuan, Doctor, +86-025-83718836-3638, yuansongtao@vip.sina.com

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200000

    Xiaodong Sun, PHD

    Fenghua Wang, Doctor, +86-021-36216424, smilefh@126.com

    Recruiting

  • Chinese PLA General Hospital of Central Theater.

    Wuhan, Hubei, 430000

    YanPing Song, PhD

    Ya Ye, Doctor, +86-027-50772574, 470902810@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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)

Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.

Read the detailed description

According to the results of preclinical pharmacological research and clinical application of bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the treatment of ocular diseases such as DME .Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.

Being tested
Drug 601
Keywords
VEGF; DME; bevacizumab; safety

What participants receive

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

  • Drug 601Drug

    Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.

Study groups in NCT04151407
Study groupRoleWhat they receive
601 dose level 1 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
Receives: Drug: Drug 601
601 dose level 2 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once
Receives: Drug: Drug 601
601 dose level 3 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once
Receives: Drug: Drug 601
601 dose level 4 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
Receives: Drug: Drug 601
601 dose level 5 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(3.75mg), Vitreous injection, injection once;
Receives: Drug: Drug 601
601 dose level 6 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously.
Receives: Drug: Drug 601
601 dose level 7 treatmentExperimentalRecombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously.
Receives: Drug: Drug 601

What is being measured

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

  1. DLT

    Incidence of dose-limiting toxicities up to the Day 28

    Measured: From Day 0 up to Day 28

  2. MTD

    Maximum tolerated dose

    Measured: From Day 0 up to Day 56/112.

Secondary outcomes (9)

  1. Cmax

    The maximum blood concentration after 601 drug enters the bloodstream

    Measured: From Day 0 up to 56/112 days

  2. t1/2

    The half-life of drug 601, the time required for the terminal phase 601 drug concentration to drop by half

    Measured: From Day 0 up to 56/112 days

  3. AUC

    Area under the concentration-time curve, reflect the characteristics of the exposure of 601 drug in the body.

    Measured: From Day 0 up to 56/112 days

  4. Vd

    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

    Measured: From Day 0 up to 56/112 days

  5. CL

    Clearance rate of drug 601 from the central ventricle.

    Measured: From Day 0 up to 56/112 days

  6. MRT

    The average length of time that the 601 drug stays in the body.

    Measured: From Day 0 up to 56/112 days

  7. λz

    the ratio of the amount of elimination of 601 drug from the body per unit time to the total amount in the body

    Measured: From Day 0 up to 56/112 days

  8. Biomarker

    Detection of VEGF concentration

    Measured: From Day 0 up to 56/112 days

  9. Immunogenicity

    Development of Anti-drug antibodies (ADA) after IVT injection of 601

    Measured: From Day 0 up to 56/112 days

Timeline

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

  1. First posted5 Nov 2019
  2. Study start8 Mar 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (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
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151407
Sponsor's protocol ID
SSGJ-601-DME-I-01
Status last verified
Aug 2019
First submitted
31 Oct 2019
Last updated
5 Nov 2019
Results posted
No
Data monitoring committee
No
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 Drug 601 in people with Diabetic Macular Edema, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites 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 10 inclusion and 38 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Results are not available in the source record.

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

Contact Xiaodong Sun, PhD (+86-021-36216424, xdsun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: From Day 0 up to Day 28). The study lists 2 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 NCT04151407.

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 5 Nov 2019.

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