Age-related macular degeneration
Conditions
Interventions
EXG202 injection Group:EXG202 injection single intravitreal injection
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, age >=50 years old; 2. The study eye must meet the following criteria: A. Confirmed diagnosis of wAMD with active lesions, defined as the presence of any of the following lesions in the macular area by OCT: a) Intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. BCVA scores detected at screening using the ETDRS visual acuity chart (see Appendix 3 for details) must be between 73-19 letters (including cut-off values) (equivalent to 20/40 to 20/400 of Snellen's visual acuity); 3. Clinically significant response to standard anti-VEGF therapy within 6 months prior to screening or during the screening lead-in period. A clinically significant response is defined as a decrease in retinal thickness, subretinal effusion, or intraretinal fluid that meets at least one of the following: a) at least 50 µm improvement if CRT is less than 400 µm; b) at least 15% improvement if CRT is above 400 microns; c) Subretinal effusion or intraretinal effusion as assessed by the investigator is less than before treatment. 4. Subjects have clear refractive media and adequate pupil dilation at screening in order to obtain high-quality retinal images to confirm the diagnosis; 5. Subjects (including male subjects) have no pregnancy plan during the screening period and the whole trial period and voluntarily take effective contraceptive measures and have no sperm donation and egg donation plans; 6. Voluntarily participate in this clinical trial, understand the study procedures and sign the informed consent form before screening; Good compliance with study procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of any ocular disease (such as macular hole, epimacular membrane, etc.) in the study eye other than wAMD that may affect central vision and/or macular detection; 2. The study eye has a history of retinal detachment in the past or has retinal detachment during the screening period (such as rhegmatogenous retinal detachment, traction retinal detachment, etc.); 3. History of macular pathology unrelated to wAMD due to MNV caused by reasons other than wAMD in the study eye (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, vascular streak lesion, ocular histoplasmosis, trauma, etc.); 4. The study eye is planned to undergo any intraocular surgery during the study; 5. The subretinal hemorrhage of the study eye accumulated in the fovea, and the hemorrhage area was >=4 DA (optic disc area); 6. Current > in the study eye = 1 + vitreous hemorrhage; 7. History of idiopathic or autoimmune-associated uveitis unrelated to ophthalmic surgery in any eye; 8. Active ocular infection in any eye (such as conjunctivitis, keratitis, scleritis, endophthalmitis, blepharitis, retinal optic neuritis, etc.); 9. Study eye with retinal angiomatosis hyperplasia (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome; 10. Presence of glaucoma or optic neuropathy involving or jeopardizing the central visual field of the study eye or presence of uncontrolled high intraocular pressure in the study eye, defined as currently receiving >=2 intraocular hypotensive drugs; 11. Previous intraocular hypertension secondary to hormonal therapy (defined as: intraocular pressure > 22 mmHg within 30 days after receiving topical, periocular or IVT or systemic hormone therapy or the need for symptomatic treatment with intraocular hypotensive drugs); 12. The spherical equivalent of the refractive error of the study eye showed a myopic >8 diopters; 13. Presence of the following diseases: a) Unstable or severe cardiovascular disease, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), unstable angina, congestive heart failure or severe arrhythmia or severe limb ischemia requiring medication; b) Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and diastolic blood pressure > 100 mmHg after adequate treatment with antihypertensive drugs; c) glycosylated hemoglobin (HbA1c) > = 7.0 %; d) Cerebrovascular disease within 12 months prior to screening, which is judged by the investigator to be unsuitable for participation in this trial or will affect the evaluation of the subject; e) the presence of neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease) that, in the judgment of the investigator, would affect the investigator's evaluation of the subject; f) Those who have a history of malignant tumors within 5 years before the first dose (except for the following tumor diseases: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma in situ of the thyroid, carcinoma in situ of the colorectum, etc., which have been controlled by treatment); g) Disease requiring immunosuppressant therapy during the study period; 14. Patients with abnormal liver function: a) alanine aminotransferase (ALT) >=3 × ULN (upper limit of normal); b) aspartate aminotransferase (AST) >=3× ULN; 15. Serovirological examinat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess treatment-emergent adverse events (AEs) and serious adverse events (SAEs) through Week 52 by organ system and incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity, BCVA; | — |
Countries
China
Contacts
Public ContactWang Lifei
Hebei Eye Hospital
Outcome results
None listed