wet age-related macular degeneration
Conditions
Interventions
1:25mg dose
2:50mg dose
3:75mg dose
4:100mg dose
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged = 50 years; 2. Fluorescein angiograms (FA) and optical coherence tomography imaging (OCT) proved to have a secondary to AMD active choroid neovascularization (CNV) formed, at the same time test characteristics for the eye with the following: 1) under the macular or nearly in the macular area damage area of < 12 DVD area; 2) the retinal hemorrhage is less than 50% of the damaged area; 3) scar or fibrosis less than 50% of the total area of injury. 3. Always not received anti VEGF drugs (such as: licensed resistance, bevacizumab or BaiXiPu o) treatment or have previously anti VEGF (licensed resistance, bevacizumab or BaiXiPu o) stop drug treatment and effective more than 3 months, but proved to have a subretinal effusion, OCT macular edema sac sample and (or) retinal thickening to more than 250 microns, need other drugs. These include subjects requiring routine injection and active lesions; 4. Eyes with wAMD, such as the eye vision of ETDRS, are in the range of 20/32 to 20/400 of BCVA. If only one eye can achieve this vision scope and the other is equal to or beyond the BCVA or equal to 20/32, 20/400 is only set up in accordance with the scope of vision eye for eye test, equal or exceed the range of vision eye also need to complete all the eye exam items, but not included in the efficacy of statistical analysis; 5. Normal or abnormal blood test is abnormal without clinical significance; 6. The normal upper limit (ULN) or international standardized ratio (INR) of PT/APTT in the research unit is less than or equal to 1.1; 7. Normal liver function: 1) total bilirubin was lower than normal value; 2) normal-value upper limit of the research unit of glutamate-transaminase and rice straw transaminase; 8. Renal function: blood creatinine is less than the normal value of the research unit; 9. Oral medication; 10. Can understand and be willing to sign informed consent, follow the research plan and be able to accept all research observations.
Exclusion criteria
Exclusion criteria: 1. ICG imaging was diagnosed as polypoid choroid angiopathy; 2. Early acceptance of photodynamic therapy (PDT) (in the four months before screening), in vitro radiotherapy, in macular area laser photocoagulation therapy, macular surgery or through pupil temperature and heat treatment; 3. The CNV rather than for other diseases caused AMD, including eye tissue cell cytoplasm fungi syndrome, blood vessels, changes in the sample strips, multifocal choroiditis, choroid rupture or pathological myopia (mirror ball - 8 diopter or higher); 4. The experimental eye and the concave of the central concave; 5. In addition to AMD, the experimental retinal vascular disease or retinal degeneration is caused by other diseases; 6. Test the eye have any disease that can damage the best corrected vision, such as glaucoma associated with clear vision loss, severe glaucoma and difficult to control with medicine, clinically significant diabetic macular edema, fertile diabetic retinopathy, ischemic neuropathy, uveitis, including retinal vein occlusion and pigment retinitis pigmentosa, retinal vascular lesions; 7. Cataract surgery was performed within 3 months before screening; 8. The test eye was done with trabeculectomy, aqueous shunt or regulating valve implantation; 9. Intraocular intraocular surgery was performed within 3 months before the screening, for example, intraocular lens capsule tomy or iridotomy was performed 30 days prior to entry; 10. Test eye height myopia (the ball mirror is -8 diopter or lower); 11. An incomplete pupil dilation or significant interstitial turbidity in the eye, which interferes with the visual acuity or the immediate evaluation (including the bottom of the eye); 12. Clinical trials of any trial medication or any other experimental or experimental therapy may be performed within 30 days prior to baseline examination; 13. Women of childbearing age are in pregnancy, lactation or unmedicated contraceptives; Men who don't want to take birth control; 14. Severe allergic or previous serious side effects on fluorescence. However, subjects do not need to rule out that the nausea or itch caused by fluorescein may be restored after treatment with anhydramine or not included in this study; 15. For the first time in stage screening or screening and baseline observed by an acute illness, cannot be confirmed, or researchers think serious disease composition test security problems at the same time, including evidence-based clinical severe or recorded in the history of the blood system, kidney, endocrine, lung, gastrointestinal tract, cardiovascular, nervous or allergic diseases, liver, spirit, not including untreated and no clinical symptoms of seasonal allergic disease; 16. In a period of 6 months before the start of treatment appeared serious heart disease, patients with clinical symptoms of congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery reconstruction, and arterial thrombosis, poor control of blood pressure and need further treatment of ventricular arrhythmia. (in the case of taking or not taking blood pressure medication, the patient recorded the median blood pressure in the journal during the screening period, which was 14/90 MMHG, or the heart rate was greater than 120 times/min, and confirmed after the follow-up review); 17. QTc acuity 450 msec or subjects had advanced reverse core dynamic risk factors (such as tachycardia familial long QT syndrome, left vent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ETDRS best corrected visual acuity;Fluorescein angiography;Retinal thickness changes under OCT;The changes of CNV after 6 months compared with the baseline;The ratio of CNV of the contralateral eye of the subjects;Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactWei Wenbin
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed