This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab in Patients With wAMD
A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Ming Guo
- Phone Number: +86-10-58628288-9127
- Email: ming_guo@sinocelltech.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Beijing Tongren Hospital
-
Principal Investigator:
- wei wenbin
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent form;
- Age≥45 years,male or femal;
- The study eye must meet the following criteria: Diagnosis of wAMD; Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to wAMD; The total lesion area ≤ 30mm2; The BCVA letters between 19 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts;
- The study eye has not received any anti-VEGF treatment within 3 months before randomization, such as ranibizumab, bevacizumab, conbercept, etc;
Exclusion Criteria:
- Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye;
- Significant afferent pupillary defect (APD) in the study eye;
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥1 month before randomization) in the study eye.
- The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, vitreous macular traction syndrome, optic nerve disease, etc.);
- CNV caused by non-nAMD exists in the study eye (such as trauma, ocular histoplasmosis, vascular stripes, etc.);
- The study eye has high myopia with diopter≥8D;
- The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), or has received glaucoma filtering surgery;
- Vitreous hemorrhage in the study eye before randomization;
- Any history of the following ophthalmic surgery in the study eye: vitrectomy, macular transposition; any evidence of external eye surgery within 1 month, cataract surgery within 2 months or other intraocular surgery within 3 months before randomization in the study eye;
- Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, or endophthalmitis, ect;
- Previous IVT injection of any anti-VEGF drug into fellow eye within 3 months before randomization;
- Fellow eye uses ETDRS testing to detect BCVA <19 letters;
- Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study;
- Abnormal liver and kidney function (ALT, AST≥2.5 times the upper limit of normal; total bilirubin≥1.5 times the upper limit of normal; serum creatinine≥1.5 times the upper limit of normal);Abnormal coagulation function(prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN);
- Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat);
- History of a medical condition, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.) within 6 months before randomization;
- Any history of surgery within 1 month before randomization, and/or any currently unhealed wounds, ulcers, fractures, etc.;
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases before randomization; uncontrolled diabetes (defined as HbA1c>10.0%);current treatment for active systemic infection;
- Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
- Pregnant, lactating women and the patients who can not take contraceptive measures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: SCT510A
SCT510A(1.25mg),
Vitreous injection, injection once every 4 weeks
|
SCT510A,1.25mg,IVT
|
|
Active Comparator: Ranibizumab
Ranibizumab(0.5mg), Vitreous injection, injection once every 4 weeks
|
ranibizumab,0.5mg,IVT
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change from baseline in BCVA at at Week 48
Time Frame: up to at Week 48
|
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 48.
|
up to at Week 48
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients gaining at least 5,10,15 letters in the BCVA at Week 12, 24 and 48
Time Frame: up to Week 12, 24 and 48
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
|
up to Week 12, 24 and 48
|
|
Mean change from baseline in BCVA at at Week 12 and 24
Time Frame: up to Week 12 and 24
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
|
up to Week 12 and 24
|
|
Mean change from baseline in CRT on OCT at Week 12, 24 and 48 (as measured by the Reading Center)
Time Frame: up to Week 12,24 and 48
|
up to Week 12,24 and 48
|
|
|
Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12 and 48 (as measured by the Reading Center)
Time Frame: up to Week 12 and 48
|
up to Week 12 and 48
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SCT510A-A301
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.
Clinical Trials on Wet Age-related Macular Degeneration
-
NCT04480463CompletedNeovascular Age-related Macular Degeneration | Wet Age-related Macular Degeneration
-
NCT05197270RecruitingNeovascular (Wet) Age-Related Macular Degeneration
-
NCT04832724CompletedWet Macular Degeneration | Neovascular Age-related Macular Degeneration | Wet Age-related Macular Degeneration
-
NCT06888492Not yet recruitingWet Age-related Macular Degeneration | Wet Age-related Macular Degeneration (wAMD)
-
NCT06704009CompletedWet AMD | Wet Age Related Macular Degeneration
-
NCT02634970WithdrawnWet Age-related Macular Degeneration (Wet AMD)
-
NCT04935411TerminatedNeovascular Age-Related Macular Degeneration
-
NCT04662944Completed
-
NCT05126966Withdrawn
-
NCT00383370CompletedNeovascular Age Related Macular Degeneration
Clinical Trials on SCT510A
-
NCT04564937UnknownWet Age-related Macular Degeneration