Wet age-related macular degeneration (wAMD)
Conditions
Interventions
Experimental group:Ginkgo biloba demethylketone ester desilting tablet, 4 tablets/time, orally, twice a day, for 12 weeks.
Control group:Ginkgo biloba demethylketone desilting tablet simulator, 4 tablets/time, orally, twice a day for 12 weeks.
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=50 years old, gender unlimited; 2.To study patients with wet age-related macular degeneration who had been treated with anti-VEGF; 3.The total area of eye lesions (including bleeding, scar and neovascularization) was less than 12 optic discs (DA). 4.The BCVA detected by ETDRS eye chart was 73~34 letters (including boundary values), which was equivalent to 20/40 ~ 20/200 of Snellen eye chart. 5.Informed consent signed voluntarily by the patient or his legal representative; 6.The subjects were able to maintain good communication with the investigators and comply with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. The study eye has subretinal or intraretinal hemorrhage with the hemorrhage area >=50% of the total lesion area, or the hemorrhage is located under the fovea centralis and the area is >=1 optic disc area (DA); 2. The study eye has scars, fibrosis, atrophy involving the fovea centralis or dense hard exudation under the fovea centralis; 3. Study the presence of CNV in the eyes that is not caused by wAMD (such as trauma, pathological myopia, multifocal choroiditis, histoplasmosis of the eye, and vascular streaks); 4. The study eye has any ocular diseases or medical history other than wAMD that may affect central vision and/or macular detection (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, epiretinal membrane, retinal pigment epithelium tear involving the macula, vitreous macular traction syndrome, optic nerve diseases, etc.); 5. The study eye had undergone internal eye surgery (such as cataract extraction, vitrectomy, macular laser photocoagulation therapy, etc.) within 90 days before the first administration or external eye surgery within 30 days. 6. The study eye has a history of corneal transplantation or corneal dystrophy; 7. There was vitreous hemorrhage in the study eye within 30 days before the first administration; 8. The study eye had received intraocular or systemic administration of corticosteroids within 90 days before the first administration, or had received peribulbar administration of corticosteroids within 30 days before the first administration. 9. The study eye has poorly controlled glaucoma (defined as intraocular pressure remaining >=21mmHg after anti-glaucoma treatment), and/or has undergone glaucoma filtering surgery (such as trabeculectomy, sclerectomy, non-penetrating trabeculectomy, etc.); 10. The study eye has no lens (except for intraocular lens eyes) or posterior capsule rupture of the lens (except for yttrium-aluminum-garnet (YAG) laser posterior capsule incision after intraocular lens implantation more than 30 days before the first administration); 11. Where the intraocular conditions of the eye under study may require the use of prohibited drugs or surgical intervention during the study period; 12. The study eye has refractive media opacity and/or pupil constriction that affect fundus examination or OCT imaging; 13. The equivalent spherical refractive power of the study eye before any possible refractive correction or cataract surgery is greater than or equal to -8D; 14. The studied eye has scleral softening syndrome; 15. Either eye has undergone surgical treatment other than laser photocoagulation (such as photodynamic therapy (PDT), external radiation, transpupillary thermotherapy, and other submacular surgeries, etc.); 16. There is a history of uveitis in either eye; 17. There is active inflammation or infection within, outside or around the eye in either eye; 18. One-eyed patients; 19. Known to be allergic to fluorescein, povidone iodine or indocyanine green or the active ingredient of the investigational drug and its excipients; 20. Myocardial infarction and/or cerebral infarction occurred within 180 days prior to the first administration; 21. Suffering from systemic immune diseases; 22. At present, there are serious infectious diseases that require systemic treatment; 23. There is uncontrollable hypertension (defined as a sitting systolic blood pressure of >=160mmHg or a diastolic blood pressure of >=95mmHg after antihypertensive drug treatment); 24. People with th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects receiving anti-VEGF reinjection in both groups within 12 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean number of reinjections of anti-VEGF in the two groups within 12 weeks;;The number of letters of best corrected visual acuity (BCVA) improvement from baseline at week 4, week 8, and week 12 during the study, as assessed by the ETDRS eye chart;;The proportion of subjects with BCVA improvement of =5, =10, =15 letters from baseline at week 4, week 8, and week 12, as assessed by ETDRS visual acuity chart;;Changes in central retinal thickness (CRT) relative to baseline as assessed by optical coherence tomography (OCT) at weekend 4, 8, and 12;;Changes in the area of choroidal neovascularization (CNV) leakage relative to baseline at the end of week 12, as assessed by FA.;Whole body safety;Eye safety; | — |
Countries
China
Contacts
Public ContactWang Lifei
Hebei Eye Hospital
Outcome results
None listed