Age-related macular degeneration
Conditions
Interventions
Low-dose group:Administer 0.05 mg of Tregexo plus 0.5 mg of ranibizumab.
Medium-dose group:Administer 0.5 mg of Tregexo plus 0.5 mg of ranibizumab.
High-dose group:Administer 1.5 mg of Tregexo plus 0.5 mg of ranibizumab.
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: All of the following criteria will be met: 1. Understand and sign the informed consent form, and be willing to follow up according to the time specified in the trial; 2. Age 50-85 years old (including boundary value), male or female; 3. Subjects with confirmed diagnosis of neovascular age-related macular degeneration in the study eye, and confirmed by imaging examination that there are still active lesions at present. Active lesions are defined as the presence of any of the following lesions in the macula: a. intraretinal fluid; b. Intraretinal lipid exudation; c. Subretinal fluid; d. Subretinal hemorrhage; e. Retinal pigment epithelial detachment; f. choroidal neovascular leakage; 4. The total area of the study eye lesion <=30mm2 (12 optic disc areas), confirmed by the designated reader; 5. The BCVA of the study eye at the screening period and baseline is 73-19 letters (using the ETDRS visual acuity chart with boundary values), which is equivalent to Snellen visual acuity 20/40 to 20/400; 6. Patients who did not respond to VEGF antibody (ranibizumab) treatment: After 3 consecutive anti-VEGF treatments, the central retinal thickness (CRT) and best corrected visual acuity (BCVA) showed no improvement compared with those before treatment.
Exclusion criteria
Exclusion criteria: Patients cannot enter this study if they meet any of the following criteria: 1. Within 3 months before the screening of the study eye, received any intravitreal anti-VEGF therapy other than ranibizumab (such as bevacizumab, aflibercept, conbercept, etc.); 2. The following treatments have been received within 3 months prior to screening in the study eye: veteporfin photodynamic therapy (PDT), macular laser photocoagulation, transpupillary thermotherapy (TTT), and other surgeries for the treatment of wAMD; 3. The study eye has undergone the following ophthalmic surgeries: vitrectomy, anti-glaucoma surgery, macular transposition. Internal eye surgery (including cataract surgery) within 3 months before screening in the study eye, or external eye surgery within 1 month before screening; 4. Intravitreal injection therapy (such as triamcinolone acetonide, dexamethasone) within 3 months before the screening of the study eye, intravitreal injection of dexamethasone extended-release agent within 6 months, and intraocular intraocular or periocular or subconjunctival injection of long-acting corticosteroid drugs (such as triamcinolone acetonide, etc.) in any eye within 3 months before screening; 5. The study eye is combined with ocular diseases that affect central vision (such as diabetic retinopathy, retinal vein occlusion, uveitis, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis, optic nerve disease); 6. Geographic atrophy, scarring or fibrosis involving the fovea, dense subfoveal hard exudation, and retinal pigment epithelium (RPE) tear involving the center of the macula in the study eye (confirmed by the designated reader at screening); 7. Presence of choroidal neovascularization not caused by wAMD, progressive retinopathy affecting corrected visual acuity, vitreous hemorrhage or history of vitreous hemorrhage in either eye, or history of retinal detachment; 8. Equivalent spherical lens of refractive error in the study eye shows more than -6.0 diopters. For patients who have undergone prior refractive surgery or cataract surgery, the refractive error in the preoperative study eye should not exceed -6.0 refractive degrees; 9. The study eye is aphakic (excluding intraocular eye) or posterior lens capsule rupture (except for YAG laser posterior capsulotomy after intraocular lens implantation more than 1 month from screening); 10. The study eye has obvious refractive interstitial opacity or pupil inability to dilate, including cataract and corneal opacity, which may interfere with visual acuity assessment, safety assessment or fundus photography and other examinations; 11. The study eye has an afferent pupillary defect (APD); 12. Presence of uncontrolled glaucoma in the study eye prior to screening, defined as intraocular pressure still higher than 25mmHg after drug treatment, or as judged by the investigator; 13. Received photodynamic (PDT) therapy within 1 month prior to screening in non-study eyes; 14. History of idiopathic or autoimmune-associated uveitis in any eye; 15. Pseudocapsular decortication syndrome in any eye; 16. Active ocular infection in any eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis); 17. Currently using or may need to use systemic drugs that can cause crystal toxicity or retinal toxicity, such as deferrigin, chloroquine/hydroxychloroquine, phenothiazine, ethambutol or tamoxifen, etc.; 18. Have a history of alle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central retinal thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity; | — |
Countries
China
Contacts
Public ContactYong Tao
Hebei General Hospital
Outcome results
None listed