| Eligibility |
Inclusion Criteria:
- Only the following criteria are met:
1. The patient or his legal representative authorized by the patient signs the
informed consent, fully understands the test content, process and possible
adverse reactions, and is willing to follow up within the time specified in the
test;
2. Age 50-85 years old (including boundary value), male or female;
3. The patient diagnosed with active choroidal neovascularization (CNV) disease
secondary to wet age-related macular degeneration is confirmed by the reading
center during screening;
4. The total area of research eye lesions = 30mm2 (12 optic disc areas), confirmed
by the reading center before random enrollment;
5. At the time of screening and baseline, the BCVA of the study eye was 73-24
letters (using the ETDRS visual acuity table, including the boundary value)
(equivalent to the snellen visual acuity score of the study eye of 20/40 to
20/400);
6. At the time of screening and baseline, the contralateral eye BCVA = 34 letters
(using the ETDRS visual acuity table, which is equivalent to snellen vision =
20/200). For the subjects in the PK group, the investigator must judge that the
contralateral eye is expected to be 3 No anti-VEGF treatment is required within a
month.
Exclusion Criteria:
- If a patient meets any of the following conditions, they cannot enter the study:
Those with the following eye conditions:
1. The research eye has map-like atrophy involving the fovea, scars or fibrosis, anterior
macular membrane, dense exudate hard exudation, RPE tear, etc. (confirmed by the
reading center during screening);
2. Research eye retinal hemorrhage = 4 optic disc areas (confirmed by the reading center
during screening);
3. The research eye has significant interference with vision detection, anterior segment
and fundus assessment of the refractive medium is turbid or the pupil is not dilated;
4. The research eye is combined with other fundus diseases (such as diabetic retinal
degeneration, retinal vein occlusion, vascular streaking, pathological myopia, retinal
detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);
5. The research eye has pupil afferent defects (APD)
6. There are uncontrolled glaucoma in the research eye at the time of screening and
baseline, defined as the intraocular pressure is still higher than 21mmHg after drug
treatment, or according to the investigator's judgment;
7. The pre-screening research eye had received dexamethasone intravitreal implant
(Ozurdex) treatment or fluocinolone intravitreal implant (Iluvien) treatment;
8. Within 3 months before the screening, the research eye had received the following
treatments: photodynamic therapy (PDT), total retina laser photocoagulation, macular
laser photocoagulation, transpupillary thermotherapy, etc., for AMD therapy;
9. The research eye has undergone the following ophthalmic operations: vitrectomy,
macular transposition, anti-glaucoma surgery;
10. Have undergone external eye surgery or cataract surgery within 3 months before the
study eye screening or during the study period;
11. The study eye has no lens (excluding intraocular lens) or posterior lens capsule
rupture (except YAG laser posterior capsulotomy after implantation of intraocular lens
more than 1 month after screening);
12. Contralateral eye received photodynamic (PDT) treatment within 1 month before
screening;
13. A history of uveitis in any eye;
14. Vitreous hemorrhage in any eye during the screening period or history of vitreous
hemorrhage within 4 weeks before baseline;
15. Any eye has pseudocapsular exfoliation syndrome;
16. Any eye has active eye infection (eg: blepharitis, infectious conjunctivitis,
keratitis, scleritis, iridocyclitis, endophthalmitis);
17. Within 3 months before the screening, any eye had received intravitreal injection of
anti-VEGF drugs (such as abecept, compaq, ranibizumab, bevacizumab, etc.);
18. Injection of corticosteroid drugs (such as triamcinolone acetonide, dexamethasone,
etc.) into any eye, periocular or subconjunctival eye within 3 months before
screening;
Those with any of the following general conditions:
19. Currently in use or may need to use systemic drugs that may cause crystal toxicity or
retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine,
ethambutol or tamoxifen, etc.;
20. Have an allergic reaction or history of fluorescein sodium and indocyanine green, have
a history of allergy to protein products for treatment or diagnosis, or are known to
have allergic reactions to any monoclonal antibody;
21. Previously received systemic anti-VEGF treatment;
22. Patients with large doses of oral or injectable corticosteroids and other hormonal
drugs (>10 mg prednisolone or the same dose/day) within 6 months before screening, but
patients who use steroid drugs for inhalation, nasal cavity or local skin small doses
except;
23. Poorly controlled diabetic patients are defined as glycated hemoglobin> 10%;
24. Those who had surgery within 1 month before screening and did not heal, or according
to the judgment of the investigator;
25. There are clinically significant systemic infectious diseases that require intravenous
antibiotic therapy;
26. Those who have a history of myocardial infarction, cerebral infarction and angina
within 6 months before screening;
27. Those who have active disseminated intravascular coagulation and obvious bleeding
tendency within 3 months before screening, or have received anticoagulant and
antiplatelet therapy except aspirin/NSAIDs within 14 days before screening;
28. Hypertension patients with poor control (defined as blood pressure >160/100 mmHg after
treatment with antihypertensive drugs);
29. Any uncontrollable clinical problems (such as severe mental, neurological,
cardiovascular, respiratory and other system diseases and malignant tumors);
Those with abnormalities in any of the following laboratory tests:
30. Abnormal liver and kidney function (this test stipulates that ALT and AST shall not be
higher than the upper limit of the normal value of the laboratory in the center by 2.5
times; Crea and BUN shall not be higher than the upper limit of the normal value of
the laboratory in the center by 2 times);
31. Patients with abnormal blood coagulation function (prothrombin time> upper limit of
normal value 3 seconds or activated partial thromboplastin time> upper limit of normal
value 10 seconds);
32. Any one of the following infected patients: active hepatitis B (if HBsAg(+) requires
HBV DNA must be >500 IU/mL or the hospital maximum limit), hepatitis C, AIDS or
syphilis (syphilis RPR positive test) ;
Women and men of childbearing age in any of the following situations:
33. Women who are pregnant, pregnant or breastfeeding (pregnancy is defined as a positive
blood/urine pregnancy test in this trial); male or female subjects of fertility do not
agree to the entire study period and within 3 months after the end of the visit period
Take appropriate contraceptive measures (such as IUDs, birth control pills or condoms,
etc.). For women who have not been menopausal or have been menopausal but have not met
the menopause time continuously for more than 12 months, and have not undergone
sterilization surgery (ovarian and/or hysterectomy), they are defined as having
fertility. The definition of fertility may be adjusted according to local standards in
each region.
Note: High-efficiency contraception methods include total abstinence, IUD, double
barrier method (eg condom + diaphragm with spermicides, implanted contraceptives,
hormonal contraceptives [contraceptives, implanted contraceptives, transdermal
Patches, hormone-vaginal appliances or sustained-release injections], or the partner
has undergone vasectomy and is confirmed to have no sperm); other:
34. Those who have participated in clinical trials of any drugs (excluding vitamins and
minerals) within 3 months before screening;
35. The researchers believe that those who need to be excluded.
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