Age-related cataract and macular degeneration
Conditions
Interventions
Observation group:None
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects or their guardians have signed a written informed consent form, and are willing to participate in the study and follow the protocol and be followed up to 6 months (180±7 days) after cataract surgery; 2. Age>=50 years old, and <=80 years old; 3. Choroidal neovascularization (CNV) secondary to nAMD confirmed by fundus fluorescence angiography (FFA) or optical coherence tomography (OCT) of the study eye; Within 4. Within 6 months, the study eye had disease activity confirmed by OCT, manifested as intraretinal fluid (IRF), subretinal fluid (SRF) or sub-RPE fluid (sub-RPEF), etc.; 5. The BCVA of the study eye using subjective refraction was between 0.05~0.5; 6. The study eye has received anti-VEGF therapy and has responded to anti-VEGF therapy; 7. The presence of cataract with obvious symptoms and/or signs in the study eye, or the opacity of the lens makes it impossible to obtain sufficiently clear fundus imaging data (such as OCT, fundus photography, etc.).
Exclusion criteria
Exclusion criteria: 1. Concomitant ocular disease in the study eye at screening or baseline, as judged by the investigator, may result in the subject not responding to study treatment, or confounding the interpretation of study results. This includes, but is not limited to: epimacular membrane with loss of macular fovea depression, vitreomacular traction affecting central vision, active diabetic retinopathy involving the macular fovea, macular hole, rhegmatogenous retinal detachment, optic neuropathy, retinal lattice-like degeneration, spherical equivalents of the study eye=26.5mm, etc. 2. Subretinal fibrosis or atrophy involving the locus fovea; 3. The total area of CNV on FFA > 12 DA; 4. Retinal detachment in the study eye at any time; 5. Idiopathic or autoimmune uveitis in the study eye at any time; 6. The BCVA of the contralateral eye of the study eye was lower than that of Snellen visual acuity 20/400; 7. Presence of uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30mmHg after standard treatment); 8. Presence of CNV or macular edema secondary to etiology other than nAMD in the study eye; 9. The study eye has undergone vitrectomy surgery; 10. Gene therapy in either eye; 11. Presence of uncontrolled hypertension, defined as systolic blood pressure > = 160 mmHg, or diastolic blood pressure > = 100 mmHg. If the initial measurement exceeds the above limits, the test can be retested on the same day or on another day during the screening period; If the subject takes oral antihypertensive drugs, he must be on the same drug for at least 30 days before screening; 12. Diabetic patients with any of the following conditions: (1) Known macrovascular complications; (2) Glycosylated hemoglobin (HbA1c) within 28 days before screening >8.0%; (3) Patients treated with more than two oral hypoglycemic drugs or treated with insulin or GLP-1 receptor agonists; 13. History of treated or untreated malignancy of any organ system within the past 5 years (except for squamous cell carcinoma and basal cell carcinoma of the skin that has been successfully resected and has no evidence of metastasis), cervical cancer in situ, carcinoma in situ of the prostate, or papilloma of the thyroid gland, regardless of whether there is evidence of local recurrence or metastasis; 14. Other situations that the investigator thinks are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity, BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central Foveal Thickness; | — |
Countries
China
Contacts
Public ContactXing Dongjun
Tianjin Medical University Eye Hospital
Outcome results
None listed