601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)

NCT ID: NCT04922151

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2023-07-31

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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.

Conditions

Pathological Myopic Choroidal Neovascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group I

601 1.25mg

Group Type: EXPERIMENTAL

601

Intervention Type: DRUG

intravitreal recombinant humanized anti-VEGF monoclonal antibody

group II

Ranibizuman 0.5 mg

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

intravitreal recombinant humanized anti-VEGF monoclonal antibody

Interventions

601

intravitreal recombinant humanized anti-VEGF monoclonal antibody

Intervention Type: DRUG

Ranibizumab

intravitreal recombinant humanized anti-VEGF monoclonal antibody

Intervention Type: DRUG

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

• 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

• 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);

• Non-use of effective contraception during childbearing age (except for women with spontaneous admonishment of more than 12 months)
• Pregnancy and lactation women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YouXin Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

YouXin Chen, PhD

Role: CONTACT

Chenyouxinpumch@163.com

+86-010-65296358

Facility Contacts

YouXin Chen, PhD

Role: primary

Other Identifiers

SSGJ-601-pmCNV-II-01

Identifier Type: -

Identifier Source: org_study_id