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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    60
  • sponsor
    Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Updated on 23 June 2021

Summary

To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV

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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.

Details
Condition Pathological Myopic Choroidal Neovascularization
Treatment ranibizumab, 601
Clinical Study IdentifierNCT04922151
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

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 photocoagulationYAG 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. ranibizumabbevacizumabaflibercept, 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
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