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

Last updated: June 4, 2021
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Myopia

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT04922151
SSGJ-601-pmCNV-II-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sign informed consent form and willing to be visited at the time specified in thetrial
  • 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 testingcharts (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

Exclusion Criteria:

  • CNV secondary to other causes (except pathological myopia), such asneovascularage-related macular degeneration (nAMD), polypoid choroidal vasculardisease (PCV), and secondary injury
  • The fovea has fibrosis and organochemical foci or scar or atrophy that obviouslyinvolves 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 toenrollment;
  • PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in thestudy eye at any time prior to baseline. Panretinal laser photocoagulation,YAG lasertreatment or any other ocular surgeries (e.g. cataract surgery ) in the study eyewithin 3 months prior to the baseline
  • Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomyafter 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 monthsprior to baseline General Exclusion Criteria:
  • History of allergy to fluorescein sodium and allergies to protein products fortreatment or diagnosis
  • History of stroke (cerebrovascular accident), myocardial infarction, activedisseminated intravascular coagulation or pronounced bleeding tendency in the past 6months prior to baseline
  • Diagnosed systemic immune diseases (e.g. ankylosing spondylitis, systemic lupuserythematosus, 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 malignanttumors, etc.). Malignant tumors with no metastasis or recurrence within 5 years orcancers in situ cancers are not excluded.
  • History of system use of anti-VEGF drugs (e.g. bevacizumab) within 3 months prior tobaseline Laboratory Exclusion Criteria:
  • Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal valuein the local laboratory). Renal function impairment (Cr is 1.5 times higher than theupper 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 normalvalue for 10 seconds); Other Exclusion Criteria:
  • Non-use of effective contraception during childbearing age (except for women withspontaneous admonishment of more than 12 months)
  • Pregnancy and lactation women

Study Design

Total Participants: 60
Study Start date:
June 04, 2021
Estimated Completion Date:
July 31, 2023

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    BeiJing,
    China

    Active - Recruiting

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