Last updated: June 4, 2021
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting
Phase
2
Condition
Myopia
Macular Degeneration
Treatment
N/AClinical Study ID
NCT04922151
SSGJ-601-pmCNV-II-01
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Peking Union Medical College Hospital
BeiJing,
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.