neovascular age - related macular degeneration,nAMD
Conditions
Interventions
dose group1:YHK803 injection is administered via intravitreal injection, with a dosage of 0.53µg
dose group5:YHK803 injection is administered via intravitreal injection, with a dosage of 4.25µg
dose group2:YHK803 injection is administered via intravitreal injection, with a dosage of 1.06µg
dose group3:YHK803 injection is administered via intravitreal injection, with a dosage of 2.12µg
dose group4:YHK803 injection is administered via intravitreal injection, with a dosage of 3.4µg
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent form and agree to follow-up as scheduled during the trial; 2. Age 50-85 years (inclusive), gender unrestricted; 3. The study eye must have any type of active CNV secondary to nAMD involving the fovea centralis [mainly classic, minimal classic, or occult types], as defined by OCT detection of intraretinal fluid (IRF)/subretinal fluid (SRF) or FFA detection of fluorescein leakage; 4. The best-corrected visual acuity (BCVA) measured on the Early Treatment Research Study for Diabetic Retinopathy (ETDRS) visual acuity chart at screening must be =63 letters (approximately 20/63 on the Snellen chart), with confirmed decline primarily attributable to nAMD in the study eye; 5. The study eye must have clear refractive media and pupillary conditions to meet high-quality fundus imaging requirements without affecting disease assessment.
Exclusion criteria
Exclusion criteria: 1. The study eye has any eye disease or previous medical history other than nAMD, and the investigator believes that it may affect the macular assessment or central vision (such as diabetes retinopathy, retinal vascular occlusion, retinal detachment, >= 2 macular holes, macular epiretinal membrane, macular hemorrhage, macular retinal traction, retinal pigment epithelium tear involving macular, central serous chorioretinopathy, optic neuropathy, etc.); 2. The study eye has or is suspected to have any CNV caused by reasons other than nAMD (e.g., caused by ocular histoplasmosis, trauma, pathological myopia, angioblastular lesions, choroidal rupture, or uveitis); 3. The study eye has structural retinal damage involving the fovea centralis (e.g., retinal pigment epithelial atrophy, retinal fibrosis, scarring, dense hard exudates); 4. The study eye has poorly controlled glaucoma (defined as intraocular pressure >= 25 mmHg after anti-glaucoma medication treatment, or severe glaucoma causing a cup-to-disc ratio>0.8 in the study eye) or has previously undergone or may require glaucoma surgery during the study period (e.g., trabeculectomy and non-penetrating trabeculectomy); 5. The study eye has no lens or posterior capsule of an intraocular lens (unless due to postoperative YAG lens capsulotomy within 30 days prior to screening visit); 6. The study eye has a history of corneal transplantation or corneal dystrophy. 7. Research eyes had received any of the following treatments (any ocular administration route) or surgeries: a. Anti-angiogenic drugs used within 3 months prior to screening visit, including experimental therapies (e.g., conbercept, abecarep, lezumalimab, faricimab). b. Intraocular or periorbital steroid injections administered within 3 months prior to screening visit, or dexamethasone intravitreal implants within 6 months prior to screening visit / any use of fluocinonide intravitreal implant. c. Vitrectomy procedures performed at any time, including scleral fixation, vitrectomy, radial optic nerve incision, retinal vascular sheath incision, macular transposition, etc. d. Intraocular surgeries performed within 3 months prior to screening visit, including cataract surgery. e. Retinal laser photocoagulation therapy administered within 1 month prior to screening visit. Exclusion criteria for any eye:; 8. Presence of active intraocular or periorbital infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis); 9. History of idiopathic or immune-mediated uveitis in any eye; 10. Any gene therapy or cell therapy administered at any time; 11. Unilateral eye (defined as contralateral eye ETDRS BCVA = 160 mmHg or diastolic blood pressure >= 95 mmHg in a seated position after receiving antihypertensive treatment); 15. With uncontrollable diabetes (defined as glycosylated hemoglobin (HbA1c)
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;Changes in mean central retinal thickness (CRT) compared to baseline; | — |
Countries
China
Contacts
Public ContactXiaoyan Ding
Sichuan Provincial People's Hospital
Outcome results
None listed