| Eligibility |
Inclusion Criteria:
1. Capable to fully understand and sign the informed consent form (ICF).
2. Women or men aged =50 years when signing the ICF.
3. Newly diagnosed or recurrently, active subfoveal or juxtafoveal CNV lesions secondary
to AMD in the study eye. (Active CNV was defined as leakage on FA and subretinal or
intraretinal fluid on OCT).
4. The total lesion area (including bleeding, scar and neovascularization) of the study
eye =12 disc area (DA).
5. The BCVA letters between 15 and 78, inclusive, in the study eye, using Early Treatment
Diabetic Retinopathy Study (ETDRS) charts.
6. Clear ocular media and adequate pupillary dilatation to allow acquisition of good
quality retinal images to confirm the diagnosis.
Exclusion Criteria:
1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or
atrophy involving the fovea, or CNV due to other causes in the study eye (e.g., ocular
histoplasmosis, trauma, or pathological myopia, etc.).
2. The fellow (non-study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD,
trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc) in
the next 3 months, in the investigator's judgment.
3. Active or recent (within 1 month prior to dose 1) intraocular, extraocular or
periocular infection (including but not limited to conjunctivitis, keratitis,
scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated
uveitis in either eye.
4. Vitreous hemorrhage in study eye within 3 months prior to dose 1.
5. Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except
yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens
implantation =1 month prior to first dose) in the study eye.
6. Corneal dystrophy or history of corneal transplantation, scleral softening or history
of scleral softening, history of rhegmatogenous retinal detachment or macular hole
(Stage II, III or IV) in the study eye.
7. Uncontrolled glaucoma (defined as intraocular pressure [IOP] =25 mmHg despite
treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g.,
trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.).
8. Equivalent spherical diopter of the study eye =-8D. For participants who had undergone
refractive correction or cataract surgery, the equivalent spherical diopter of the
study eye before surgery =-8D.
9. Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g.,
diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioid streaks,
retinal detachment, macular epiretinal membrane, amblyopia, central serous
chorioretinopathy, etc.) in the study eye that limited the potential to gain visual
acuity upon treatment with the investigational product, or could have required medical
or surgical intervention during the study to prevent or treat visual loss.
10. Underwent intraocular surgery including verteporfin photodynamic therapy (PDT),
transpupillary thermotherapy, macular translocation, vitrectomy, laser
photocoagulation in macular area, other surgery in macular area or surgery to treat
AMD.
11. Previous intraocular or periocular surgery within 1 month prior to dose 1(including
laser photocoagulation in juxtafoveal, cataract surgery, etc.), or current unhealed
wound, moderate or severe ulcer or history of fracture in the study eye.
12. Subconjunctival or intraocular or systemic use of corticosteroids within 3 months
(including subconjunctival or intraocular long-acting implant within 6 months).
13. Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either
eye or other ocular use of anti-VEGF drug (ranibizumab, aflibercept or conbercept)
within 3 months prior to dose 1.
14. Participated in any drug (other than vitamins and minerals) or device clinical trials
within 3 months or the duration of 5 half-lives of the study drug (which is longer)
prior to dose 1 and have used the test drug or received device treatment.
15. Pregnancy or lactation.
16. Men or women fail to meet both of the following ones: 1) women must have a negative
serum pregnancy test result within 14 days prior to initiation of the study
intervention; 2) agreement to remain abstinent (refrain from heterosexual intercourse)
or use effective contraceptive methods from signed ICF to at least 6 months following
the last dose of the study intervention. Effective contraceptive methods include
bilateral tubal ligation, male sterilization, established physical contraception and
copper intrauterine devices (IUDs).
17. Stroke or myocardial infarction within 6 months prior to dose 1, uncontrolled
hypertension (systolic blood pressure=160 mmHg, or diastolic blood pressure =100
mmHg), etc.
18. Uncontrolled diabetes (defined as HbA1c>10.0%).
19. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than
twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than
the ULN, and is clinically significant in the opinion of the Investigator.
20. Abnormal coagulation function(prothrombin time = 3 seconds over ULN, activated partial
thromboplastin time = 10 seconds over ULN)
21. Active disseminated intravascular coagulation and obvious bleeding tendency within 3
months prior to dose 1.
22. Evidence of significant uncontrolled concomitant diseases such as cardiovascular
diseases, nervous system diseases, respiratory system diseases, urinary system
diseases, digestive system diseases and endocrine diseases.
23. Current treatment for active systemic infection, or history of recurrent serious
infections.
24. Known active or suspected autoimmune diseases, requiring systemic immunosuppressive
therapy.
25. Positive for syphilis screening test or positive for human immunodeficiency virus
(HIV) screening test.
26. Known allergy to any component of the study intervention or history of allergy to
fluorescein(only for patients who cannot undergo OCT-A examination but have to undergo
ICGA examination) or indocyanine green, any anesthetics or antimicrobial agents used
during the course of the study.
27. Participant who has been diagnosed to be COVID-19 within 1 month prior to dose 1 or
who has received COVID-19 vaccine within 1week prior to dose 1.
28. In the Investigator's judgment, there is evidence of a disease or condition that
contraindicates the use an investigational drug or that might affect interpretation of
the results of the study or render the participant at high risk for treatment
complications, or other conditions considered not amenable to this study.
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