The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD)

September 21, 2020 updated by: Sinocelltech Ltd.

A Multicenter, Open-label, Multi-dose, Phase I / II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamic Characteristics of SCT510A in the Patients With Wet Age-related Macular Degeneration.

Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A）

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent form;
  2. Age≥45 years，≤80 years，male or femal;
  3. The study eye must meet the following criteria： Diagnosis of wAMD； Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to AMD； Total area of all types of lesions ≤12 optic disc areas（30mm2）； Best-corrected visual acuity of the study eye 70 letters or worse(Snellen equivalent of 20/40 or worse)； No optometric media opacity and pupil shrinkage.
  4. Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.

Exclusion Criteria:

  1. The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
  2. Significant afferent pupillary defect (APD) in the study eye；
  3. The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
  4. In addition to AMD，there are other obvious eye diseases/conditions，such as pseudoexfoliation syndrome，rhegmatogenous retinal detachment，macular hole，diabetic retinopathy and diabetic macular disease which need to be treated；
  5. CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
  6. Uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg after antiglaucoma treatment),or recevied glaucoma filtering surgery；
  7. History of vitreous hemorrhage in the study eye within 2 months before the first administration；
  8. Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, endophthalmitis, or uveitis，ect；
  9. Previous intraocular surgery ，or laser therapy for wAMD(as photodynamic therapy,transpupillary thermotherapy,etc.) in the study eye within 3 months before the first administration；
  10. Previous intraocular or periocular injection of anti-VEGF or corticosteroid drugs (such as ranibizumab, bevacizumab, conbercept, aflibercept, brolucizumab, pegaptanib sodium, anecortave acetate, triamcinolone acetonide, etc.) in either eye within 3 months before the first administration；
  11. History of allergy to fluorescein sodium or indocyanine green；
  12. PLT≤100×109/L；thrombin time and prothrombin time exceed the upper limit of normal range (based on the laboratory normal value of clinical trial institution), and the abnormality is clinically significant according to the evaluation of the investigators；
  13. Abnormal liver and kidney function；
  14. Uncontrolled blood pressure control，systolic blood pressure≥160mmhg ,or diastolic blood pressure≥100mmhg；
  15. History of surgery within one month before the first administration, or current non-healing wound, ulcer, or fracture，etc；
  16. Patients with any of the following serious systemic diseases，such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors, systemic immune system diseases, diabetes mellitus with uncontrolled blood sugar(HbA1c>10%), disseminated intravascular coagulation and significant bleeding tendency；
  17. Suffering from systemic infectious diseases requiring oral, intramuscular or intravenous administration；
  18. Pregnant, lactating women and the patients who can not take contraceptive measures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SCT510A dose level 1 treatment
SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously
Drug: SCT510A
SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 2 treatment
SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously
Drug: SCT510A
SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 3 treatment
SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously
Drug: SCT510A
SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 4 treatment
SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously
Drug: SCT510A
SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-Limiting toxicity(DLT)
Time Frame: From Day 0 up to Day 14
Incidence of dose-limiting toxicities up to the Day 14 visit
From Day 0 up to Day 14
Maximum tolerated dose(MTD）
Time Frame: From Day 0 up to Day 140
Maximum tolerated dose
From Day 0 up to Day 140

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK profile
Time Frame: From Day 0 up to 84 days
Change of SCT510A drug concentration in the blood with time
From Day 0 up to 84 days
Cmax
Time Frame: From Day 0 up to 84 days
The maximum blood concentration after SCT510A drug enters the bloodstream
From Day 0 up to 84 days
Tmax
Time Frame: From Day 0 up to 84 days
Time to the Maximum Concentration of SCT510A
From Day 0 up to 84 days
t1/2
Time Frame: From Day 0 up to 84 days
Elimination Phase Half-life of SVT510A
From Day 0 up to 84 days
Biomarker
Time Frame: From Day 0 up to 84 days
Detection of free VEGF concentration
From Day 0 up to 84 days
Immunogenicity
Time Frame: From Day 0 up to 112 days
Positive rate of ADA and NAb
From Day 0 up to 112 days
central retina thickness（CRT）
Time Frame: From Day 0 up to 140 days
Changes in CRT compared to the baseline
From Day 0 up to 140 days
Macular edema volume
Time Frame: From Day 0 up to 140 days
Changes in Macular edema volume compared to the baseline
From Day 0 up to 140 days
Best corrected visual acuity（BCVA）
Time Frame: From Day 0 up to 140 days
Changes in BCVA compared to the baseline
From Day 0 up to 140 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCT510A-A101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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