refractory macular edema, RME
Conditions
Interventions
Dose group 2:YHK803 injection is administered via intravitreal injection, with a dosage of 1.06µg
Dose group 3:YHK803 injection is administered via intravitreal injection, with a dosage of 2.12µg
Dose group 1:YHK803 injection is administered via intravitreal injection, with a dosage of 0.53µg
Dose group 4:YHK803 injection is administered via intravitreal injection, with a dosage of 4.24µg
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form and be willing to undergo follow-up visits according to the time stipulated in the trial; 2. Age between 18 and 85 years old (inclusive), gender not restricted; 3. The best corrected visual acuity (BCVA) of the screened study eye measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart is <= 63 letters (approximately 20/63 on the Snellen chart), and the decline in BCVA is determined to be mainly due to refractory macular edema; 4. Before the screening visit, the study eye has received existing standard anti-VEGF treatment (such as intravitreal injection of Conbercept, Apeirosib, Ranibizumab, Faricimab, etc.) for a long time, and the SD-OCT of the study eye shows persistent intraretinal fluid/subretinal fluid, and the investigator, based on the fundus morphology and visual function assessment, determines it to be refractory macular edema; 5. The refractive medium clarity and pupil condition of the study eye can meet the requirements for high-quality fundus imaging and do not affect the assessment of the condition.
Exclusion criteria
Exclusion criteria: 1. The study eye has any ocular disease or previous history other than refractory macular edema, and the investigator believes that it may affect macular assessment or central vision (such as vitreous hemorrhage, retinal detachment, = 2 stage macular holes, macular epiretinal membrane, retinal traction in the macular area, etc.). 2. The study eye has poorly controlled glaucoma (defined as intraocular pressure = 25 mmHg after anti-glaucoma drug treatment, or the cup-to-disc ratio of the study eye is > 0.8 due to severe glaucoma) or has received or may need to receive glaucoma surgery (such as trabeculectomy and non-penetrating trabecular surgery, etc.). 3. The study eye has no crystalline lens or posterior capsule of an artificial lens (unless it is caused by yttrium aluminum garnet [YAG] lens posterior capsule incision before 30 days before the screening visit). 4. The study eye has a history of corneal transplantation or corneal dystrophy. 5. The study eye has previously received any of the following medications (via any ocular administration route) or surgical treatments: (1) Use of dexamethasone intravitreal implant within 6 months prior to the screening visit / use of fluocinolone acetonide intravitreal implant at any time. (2) Any vitreoretinal surgery at any time, including scleral buckle surgery, vitrectomy, radial optic neurotomy, retinal sheathotomy, macular translocation, etc. (3) Any intraocular surgery within 3 months prior to the screening visit, including cataract surgery, etc. (4) Retinal laser photocoagulation within 1 month prior to the screening visit. 6. Any eye has any active intraocular or periorbital infection or active intraocular inflammation (such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis). 7. Any eye has a history of idiopathic or immune-mediated uveitis. 8. Any eye has received any gene therapy or cell therapy treatment at any time. 9. Monocular patients (defined as the contralateral eye ETDRS visual acuity = 160 mmHg or diastolic blood pressure >= 95 mmHg after antihypertensive treatment). 13. Having uncontrollable diabetes (defined as glycated hemoglobin [HbA1c] > 11% at the time of the screening visit). 14. Using or having a need to use drugs that are toxic to the lens, retina or optic nerve (such as deferoxamine, chloroquine, hydroxychloroquine [chloroquineine], tamoxifen, phenothiazines or ethambutol, etc.) during the study. 15. Having a history of myocardial infarction and/or cerebrovascular accident within 6 months before the screening visit. 16. Having a surgical history within 30 days before the screening visit, or having unhealed wounds, moderate to severe ulcers, fractures, etc. at present. 17. Having a confirmed systemic autoimmune disease (such as ankylosing spondylitis, systemic lupus erythe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types, severity, and incidence of ocular and non-ocular adverse events and serious adverse events;Tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean best corrected visual acuity (BCVA) from baseline;The mean values of P1 wave amplitude density (in nV/deg2) and latency (in ms) compared to the baseline showed changes.; | — |
Countries
China
Contacts
Public ContactMeixia Zhang
West China Hospital of Sichuan University
Outcome results
None listed