Macular DegenerationNCT03725566
JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients
A study testing Experimental in people with Macular Degeneration, run by Beijing Tongren Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2018to 1 May 2020
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
Show all 19Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
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
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;
- Conditions
- Macular Degeneration
- Being tested
- Experimental
- Keywords
- New vascular macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
Also called intravitreous injection
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Drug: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 weeks
Secondary outcomes (4)
Cmax
Maximum blood drug concentration
Measured: 13 weeks
Tmax
Peak time of blood drug concentration
Measured: 13 weeks
BCVA
The best corrected visual acuity change
Measured: 13 weeks
AUC0-t、AUCinf
The area under the plasma concentration time curves
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start22 May 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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 N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiu li zhao, doctor, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725566
- Sponsor's protocol ID
- 2017L02087
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03725566
- Acronym / sponsor ID
- 2017L02087
- Conditions
- Macular Degeneration
- Keywords
- New vascular macular degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 31 Oct 2018 (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.
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;
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ExperimentalRecombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month; |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| ExperimentalAlso: intravitreous injectionRecombinant 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 |
Primary outcome
JY028 related incidence of ocular and systemic adverse events and serious adverse events
Time frame: 13 weeks
JY028 related incidence of ocular and systemic adverse events and serious adverse events
4 secondary outcomes
Cmax
Time frame: 13 weeks
Tmax
Time frame: 13 weeks
BCVA
Time frame: 13 weeks
AUC0-t、AUCinf
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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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.
xiu li zhao, doctor principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Macular Degeneration, run by Beijing Tongren Hospital 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 2 inclusion and 19 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 31 Oct 2018. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JY028 related incidence of ocular and systemic adverse events and serious adverse events (time frame: 13 weeks). 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 31 Oct 2018.