Neovascular Age-Related Macular Degeneration
Conditions
Interventions
LX102 group:LX102/Subretinal Injection
Aflibercept group:Aflibercept/Intravitreal Injection
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written, signed informed consent for this study; 2. Age >=50 and <=80 years old; 3. active CNV secondary to nAMD in the study eye confirmed by FFA or OCT; 4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening; 5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center; 6. No anti-VEGF therapy in study eye within 28 days before screening; 7. Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).
Exclusion criteria
Exclusion criteria: 1. Any condition in the investigator's opinion that could limit VA improvement in the study eye. 2. CNV or macular edema in the study eye secondary to any causes other than AMD 3. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC; 4. History of retinal detachment in the study eye at any time; 5. History of idiopathic or autoimmune uveitis in either eye; 6. Advanced glaucoma in the study eye; 7. History of vitrectomy surgery in the study eye; 8. History of intraocular surgery within 1 month before screening in the study eye; 9. History of ocular or systemic gene therapy; 10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months; 11. History of vitrectomy surgery in the study eye; 12. History of intraocular surgery within 1 month before screening in the study eye; 13. The study eye was received intravitreal drug injection therapy other than anti-VEGF drug, such as an intraocular corticosteroid or any investigational drug, within 6 months before screening; 14. History of ocular or systemic gene therapy; 15. The study eye received macular grid or panretinal photocoagulation within 3 months before screening; 16. The study eye underwent YAG laser posterior capsulotomy or laser iridectomy within 1 month before screening; 17. Uncontrolled hypertension, defined as systolic blood pressure =160mmHg or diastolic blood pressure >=100mmHg. If the initial measurement will exceed the above limits, a repeat measurement will be performed on the same day or on another date during the screening period. 18. Glycosylated hemoglobin (HbA1c) > 8.0% within 28 days before screening; 19. Systemic anti-VEGF therapy within 3 months before screening; 20. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months. 21. A history of treated or untreated malignancy of any organ system (except successfully resected skin squamous-cell and basal cell carcinoma, cervical cancer in situ, prostate cancer in situ, or thyroid papilloma without evidence of metastasis) within the past 5 years, regardless of the presence or absence of evidence of local recurrence or metastasis; 22. Any of the following laboratory abnormalities: a. platelet count 3×ULN; c. Serum creatinine or urea > 1.5×ULN; 23. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen positivity and HBV-DNA viral load >=2000 IU/mL) at screening; Hepatitis C virus (HCV) antibody-positive; Human immunodeficiency virus (HIV) antibody-positive; Patients with syphilis specific antibody-positive and non-specific antibody test results judged by the investigator to be in the active stage or in need of treatment; 24. Received any other investigational drug (other than vitamins and minerals) within 3 months before screening (In the case of a drug, within its five half-lives, whichever is longer) or attempting to enroll in another clinical trial during the study period; 25. Pregnant or lactating women or individuals of childbearing potential who are unwilling to use effective contraception during the study period; 26. A history of a severe allergic reaction to the active ingredient, excipients, control drug of the study or a similar drug, or an history of allergic reaction to povidone-iodine; 27. Subjects who are considered unsuitable to participate in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from D0 in BCVA based on an average at weeks 40 and 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with improved BCVA at week 48;Proportion of participants with worsened BCVA at week 48;? Mean change from D0 in central subfield thickness (CST) based on an average at weeks 40 and 48;Proportion of participants without SRF/IRF on OCT at week 48;Proportion of participants with no supplemental anti-VEGF injection through 48 weeks;Proportion of participants received =2 supplemental anti-VEGF injections through 48 weeks;Mean annualized number of anti-VEGF injections after D0 through 48 weeks;Incidence of Adverse events (AE) and Serious adverse events (SAE) over 48 weeks;Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP); | — |
Countries
China
Contacts
Public ContactXiaodong Sun
Shanghai General Hospital
Outcome results
None listed