601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Pathological Myopic Choroidal Neovascularization (pmCNV)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: YouXin Chen, PhD
- Phone Number: +86-010-65296358
- Email: Chenyouxinpumch@163.com
Study Locations
-
-
-
BeiJing, China
- Recruiting
- Peking Union Medical College Hospital
-
Principal Investigator:
- YouXin Chen, PhD
-
Contact:
- YouXin Chen, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sign informed consent form and willing to be visited at the time specified in the trial
- Male or Female, at least 18 years of age
- The study eye must meet the following criteria
- Diagnosed with active choroidal neovascularization secondary to pathological myopia
- BCVA score between 78 and 24 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320)
- No optometric media opacity and pupil abnormal
- BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Exclusion Criteria:
- CNV secondary to other causes (except pathological myopia), such as neovascularage-related macular degeneration (nAMD), polypoid choroidal vascular disease (PCV), and secondary injury
- The fovea has fibrosis and organochemical foci or scar or atrophy that obviously involves the fovea and causes irreversible vision loss;
- Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to enrollment;
- PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in the study eye at any time prior to baseline. Panretinal laser photocoagulation,YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline
- Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery)
For Any Eye:
- Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis)
- History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab,bevacizumab,aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline
General Exclusion Criteria:
- History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis
- History of stroke (cerebrovascular accident), myocardial infarction, active disseminated intravascular coagulation or pronounced bleeding tendency in the past 6 months prior to baseline
- Diagnosed systemic immune diseases (e.g. ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, scleroderma etc.)
- any uncontrolled clinical problem (e.g. AIDS, active hepatitis, serious mental, neurological, cardiovascular, respiratory and other systemic diseases or malignant tumors, etc.). Malignant tumors with no metastasis or recurrence within 5 years or cancers in situ cancers are not excluded.
- History of system use of anti-VEGF drugs (e.g. bevacizumab) within 3 months prior to baseline
Laboratory Exclusion Criteria:
- Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal value in the local laboratory). Renal function impairment (Cr is 1.5 times higher than the upper limit of normal values 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);
Other Exclusion Criteria:
- Non-use of effective contraception during childbearing age (except for women with spontaneous admonishment of more than 12 months)
- Pregnancy and lactation women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: group I
601 1.25mg
|
intravitreal recombinant humanized anti-VEGF monoclonal antibody
|
|
Active Comparator: group II
Ranibizuman 0.5 mg
|
intravitreal recombinant humanized anti-VEGF monoclonal antibody
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in best-corrected visual acuity (BCVA) at Week 12
Time Frame: Baseline to Week 12
|
Assessed with ETDRS visual acuity testing charts.
|
Baseline to Week 12
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Change of BCVA on each visit compared to baseline.
Time Frame: Baseline to Week 36
|
Assessed with ETDRS visual acuity testing charts.
|
Baseline to Week 36
|
|
Change from baseline in central retina thickness (CRT) on each visit
Time Frame: Baseline to Week 36
|
OCT (optical coherence tomography) was used to assess central retina thickness (CRT) representing the average retinal thickness of the central 1 mm diameter subfield around the foveal center.
|
Baseline to Week 36
|
|
Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline
Time Frame: Baseline to Week 36
|
Assessed with ETDRS visual acuity testing charts.
|
Baseline to Week 36
|
|
Number of injections from Week 4 to Week 36
Time Frame: Week 4 to Week 36
|
Number of administered injections
|
Week 4 to Week 36
|
|
Incidence of ocular and non-ocular AEs up to Week 36
Time Frame: Baseline to Week 36
|
Incidence of ocular and non-ocular AEs
|
Baseline to Week 36
|
|
Blood concentrations of 601
Time Frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
|
Steady-state blood concentrations of 601
|
Baseline, Week 4, Week 12, Week 24 and Week 36.
|
|
Blood concentrations of VEGF
Time Frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
|
Detection of VEGF blood concentration
|
Baseline, Week 4, Week 12, Week 24 and Week 36.
|
|
Immunogenicity of 601
Time Frame: Baseline, Week 4, Week 12, Week 24 and Week 36.
|
Detection of blood Anti-drug antibody (ADA) status.
If ADA was positive, Neutralization antibody (Nab) will be tested
|
Baseline, Week 4, Week 12, Week 24 and Week 36.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Youxin Chen, PhD, Peking Union Medical College Hospital
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Uveal Diseases
- Choroid Diseases
- Refractive Errors
- Metaplasia
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Myopia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
Other Study ID Numbers
- SSGJ-601-pmCNV-II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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