601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
Primary Purpose
Pathological Myopic Choroidal Neovascularization
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
601
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Myopic Choroidal Neovascularization focused on measuring VEGF; pmCNV; antibody
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group I
group II
Arm Description
601 1.25mg
Ranibizuman 0.5 mg
Outcomes
Primary Outcome Measures
Change from baseline in best-corrected visual acuity (BCVA) at Week 12
Assessed with ETDRS visual acuity testing charts.
Secondary Outcome Measures
Average Change of BCVA on each visit compared to baseline.
Assessed with ETDRS visual acuity testing charts.
Change from baseline in central retina thickness (CRT) on each visit
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.
Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline
Assessed with ETDRS visual acuity testing charts.
Number of injections from Week 4 to Week 36
Number of administered injections
Incidence of ocular and non-ocular AEs up to Week 36
Incidence of ocular and non-ocular AEs
Blood concentrations of 601
Steady-state blood concentrations of 601
Blood concentrations of VEGF
Detection of VEGF blood concentration
Immunogenicity of 601
Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested
Full Information
NCT ID
NCT04922151
First Posted
June 4, 2021
Last Updated
June 4, 2021
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04922151
Brief Title
601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
Detailed Description
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Myopic Choroidal Neovascularization
Keywords
VEGF; pmCNV; antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group I
Arm Type
Experimental
Arm Description
601 1.25mg
Arm Title
group II
Arm Type
Active Comparator
Arm Description
Ranibizuman 0.5 mg
Intervention Type
Drug
Intervention Name(s)
601
Intervention Description
intravitreal recombinant humanized anti-VEGF monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
intravitreal recombinant humanized anti-VEGF monoclonal antibody
Primary Outcome Measure Information:
Title
Change from baseline in best-corrected visual acuity (BCVA) at Week 12
Description
Assessed with ETDRS visual acuity testing charts.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Average Change of BCVA on each visit compared to baseline.
Description
Assessed with ETDRS visual acuity testing charts.
Time Frame
Baseline to Week 36
Title
Change from baseline in central retina thickness (CRT) on each visit
Description
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.
Time Frame
Baseline to Week 36
Title
Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline
Description
Assessed with ETDRS visual acuity testing charts.
Time Frame
Baseline to Week 36
Title
Number of injections from Week 4 to Week 36
Description
Number of administered injections
Time Frame
Week 4 to Week 36
Title
Incidence of ocular and non-ocular AEs up to Week 36
Description
Incidence of ocular and non-ocular AEs
Time Frame
Baseline to Week 36
Title
Blood concentrations of 601
Description
Steady-state blood concentrations of 601
Time Frame
Baseline, Week 4, Week 12, Week 24 and Week 36.
Title
Blood concentrations of VEGF
Description
Detection of VEGF blood concentration
Time Frame
Baseline, Week 4, Week 12, Week 24 and Week 36.
Title
Immunogenicity of 601
Description
Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested
Time Frame
Baseline, Week 4, Week 12, Week 24 and Week 36.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YouXin Chen, PhD
Phone
+86-010-65296358
Email
Chenyouxinpumch@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YouXin Chen, PHD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
BeiJing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YouXin Chen, PhD
First Name & Middle Initial & Last Name & Degree
YouXin Chen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
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