Wet Age-related Macular DegenerationPhase 1NCT04468997
The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD)
A Phase 1 study testing Drug 601 in people with Wet Age-related Macular Degeneration, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Wet Age-related Macular Degeneration
- 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
- 67 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2018to 15 Sep 2021
- 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 45 to 80 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 ≥45 years and age ≤ 80 years;
- The study eye must meet the following criteria:
- Diagnosis of wAMD;
- The presence of an primary or recurrent active choroidal neovascular (CNV) lesions in subfovea and para-fovea secondary to AMD;
- Total area of all types of lesions ≤30mm2 (12 optic disc areas)
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- Best EDTRS letter score between 19 and 78(Snellen equivalent of 20/400 to 20/32);
- No optometric media opacity and pupil shrinkage.
- Best EDTRS letter score ≥19 (Snellen equivalent of 20/400 or better) in the fellow eyes.
Who cannot join
- Any of the following eye conditions:
- Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis);
- History of vitreous hemorrhage in the study eye within 2 months before screening;
- scarring, fibrosis, or atrophy below with fovea in the study eye;
- Received any drug treatment for CNV within 120 days prior to screening;
- History of any following surgery in the study eye (e.g. PDT, macular transposition, Glaucoma filtration, subfoveal photocoagulation, vitrectomy and transpupular hyperthermia, and other surgery at the submacular or others for AMD) within 3 months before screening;
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- CNV in the study eye associated with other ocular diseases such as pathologic myopia, eye trauma, etc
- History or present of uncontrolled glaucoma, history of glaucoma filtering surgery in the study eye;
- Subretinal hemorrhage in the study eye, and the bleeding area ≥ 50% area of the total lesion;
- History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage 3 or 4) , retinal detachment, retinal pigment epithelium tear or macular area traction and macular area preretinal membrane and PCV in the study eye;
- The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens;
- Any of the following general condition are present:
- Medicines with toxicity to the lens are being used or may be used during the study period;
- 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.
- History of surgery within 1 months before screening; and/or unhealed wounds, ulcers or fractures currently;
- Suffering from systemic infections and requiring oral, intramuscular or intravenous medication;
- History of stroke, myocardial infarction within 6 months before screening;
- Active diffuse intravascular coagulation and obvious bleeding tendency within 3 months before screening;
- Systemic immune diseases;
- Uncontrolled blood pressure control ;
- Diabetic patients with uncontrolled blood sugar;
- Any uncontrolled clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumours);
- Any of the following laboratory tests abnormalities(23-25):
- 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:
- Pregnancy and lactation women (pregnancy is defined as urinary pregnancy test positive in this study);
- Any other conditions:
- 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
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of Recombinant Anti-VEGF Human Monoclonal Antibody in the Treatment of Wet Age-related Macular Degeneration
Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody
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 wAMD .Observe the safety and tolerability of the single and multiple doses of 601 in wAMD 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 wAMD.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Drug 601
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
Drug 601Drug
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
| Study group | Role | What they receive |
|---|---|---|
| 601 dose level 1 treatment | Experimental | Not described Receives: Drug: Drug 601 |
| 601 dose level 2 treatment | Experimental | Not described Receives: Drug: Drug 601 |
| 601 dose level 3 treatment | Experimental | Not described Receives: Drug: Drug 601 |
| 601 dose level 4 treatment | Experimental | Not described Receives: Drug: Drug 601 |
| 601 dose level 5 treatment | Experimental | Not described Receives: Drug: Drug 601 |
| 601 dose level 6 treatment | Experimental | Not described Receives: Drug: Drug 601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Incidence of dose-limiting toxicities up to the Day 14 visit
Measured: From Day 0 up to Day 14
MTD
Maximum tolerated dose
Measured: From Day 0 up to Day 56/112.
Secondary outcomes (12)
Pharmacokinetic (PK) profile
Study the change of 601 drug concentration in the blood with time by mathematical principles and methods
Measured: From Day 0 up to 56/112 days
Cmax
The maximum blood concentration after 601 drug enters the bloodstream
Measured: From Day 0 up to 56/112 days
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
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
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
CL
Clearance rate of drug 601 from the central ventricle.
Measured: From Day 0 up to 56/112 days
MRT
The average length of time that the 601 drug stays in the body.
Measured: From Day 0 up to 56/112 days
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
Biomarker
Detection of VEGF concentration.
Measured: From Day 0 up to 56/112 days
Immunogenicity
Development of Anti-drug antibodies (ADA) after IVT injection of 601
Measured: From Day 0 up to 56/112 days
CRT
Changes in central retina thickness (CRT) at all time points compared to the baseline
Measured: From Day 0 up to 56/364 days
diseased region
Changes in the diseased region at all time points compared to the baseline
Measured: From Day 0 up to 56/364 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start12 Nov 2018
- Primary completion15 Mar 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 67 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468997
- Sponsor's protocol ID
- 3SGJ601-AMD
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Recombinant Anti-VEGF Human Monoclonal Antibody in the Treatment of Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04468997
- Acronym / sponsor ID
- 3SGJ601-AMD
- Conditions
- Wet Age-related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody
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 wAMD .Observe the safety and tolerability of the single and multiple doses of 601 in wAMD 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 wAMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 601 dose level 1 treatment | Experimental | Drug: Drug 601 |
| 601 dose level 2 treatment | Experimental | Drug: Drug 601 |
| 601 dose level 3 treatment | Experimental | Drug: Drug 601 |
| 601 dose level 4 treatment | Experimental | Drug: Drug 601 |
| 601 dose level 5 treatment | Experimental | Drug: Drug 601 |
| 601 dose level 6 treatment | Experimental | Drug: Drug 601 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign informed consent form and willing to be visited at the time specified in the trial;
- Age ≥45 years and age ≤ 80 years;
- The study eye must meet the following criteria:
- Best EDTRS letter score ≥19 (Snellen equivalent of 20/400 or better) in the fellow eyes.
Key exclusion criteria (32 listed)
- Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis);
- History of vitreous hemorrhage in the study eye within 2 months before screening;
- scarring, fibrosis, or atrophy below with fovea in the study eye;
- Received any drug treatment for CNV within 120 days prior to screening;
- History of any following surgery in the study eye (e.g. PDT, macular transposition, Glaucoma filtration, subfoveal photocoagulation, vitrectomy and transpupular hyperthermia, and other surgery at the submacular or others for AMD) within 3 months before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once; | Drug | 601 dose level 1 treatment |
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once; | Drug | 601 dose level 2 treatment |
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once; | Drug | 601 dose level 3 treatment |
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once; | Drug | 601 dose level 4 treatment |
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months. | Drug | 601 dose level 5 treatment |
| Drug 601Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months. | Drug | 601 dose level 6 treatment |
Primary outcome
DLT
Time frame: From Day 0 up to Day 14
Incidence of dose-limiting toxicities up to the Day 14 visit
MTD
Time frame: From Day 0 up to Day 56/112.
Maximum tolerated dose
12 secondary outcomes
Pharmacokinetic (PK) profile
Time frame: From Day 0 up to 56/112 days
Cmax
Time frame: From Day 0 up to 56/112 days
t1/2
Time frame: From Day 0 up to 56/112 days
AUC
Time frame: From Day 0 up to 56/112 days
Vd
Time frame: From Day 0 up to 56/112 days
CL
Time frame: From Day 0 up to 56/112 days
MRT
Time frame: From Day 0 up to 56/112 days
λz
Time frame: From Day 0 up to 56/112 days
Biomarker
Time frame: From Day 0 up to 56/112 days
Immunogenicity
Time frame: From Day 0 up to 56/112 days
CRT
Time frame: From Day 0 up to 56/364 days
diseased region
Time frame: From Day 0 up to 56/364 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug 601 in people with Wet Age-related Macular Degeneration, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 9 inclusion and 32 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 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Ming, Ph.D (+86-028-85422452, zhangmingscu@126.com), 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 14). 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?
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 13 Jul 2020.