Wet Age-Related Macular Degeneration (wAMD)
Conditions
Interventions
Group 1(Phase I ):Injection of low dose
Group 2 (Phase I ):Injection of medium dose
Group 3 (Phase I ):Injection of high dose
Dose 1 (Phase II):Injection of dose 1
Dose 2 (Phase II):Injection of dose 2
Dose 2 Cohort 1 (Phase II):Positive control (The decision on whether to add a positive control group will be made based on the results of the Phase I trial.)
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form and fully understand the trial content, procedures, and potential adverse reactions, willing to undergo follow-up visits according to the specified time and process of the trial. 2.Aged 50 to 80 years (included), male and female; 3.Diagnosis of wAMD; 4.Best-corrected visual acuity of the study eye ranging from 19 to 63 letters (ETDRS visual acuity chart, including boundary values) (with the worse eye as the study eye); best-corrected visual acuity (BCVA) of the fellow eye = 19 letters. 5. Subjects must meet the following criteria: (1)Subjects who are currently receiving anti-VEGF ophthalmic injections and have received at least 2 doses within 6 months prior to the screening period (the last dose of anti-VEGF drug should be administered at least 28 days before screening); (2)Subjects who have demonstrated a meaningful response to anti-VEGF ophthalmic therapy by prior optical coherence tomography (OCT) test (meaningful response is defined as: =50 µm decrease in CRT value from the highest value, or 30% reduction in intraretinal and/or subretinal fluid from the highest value). Long-term follow-up study inclusion criteria: 1.Signed informed consent form for long-term follow-up study, fully understand the trial content, procedures, and potential adverse reactions, willing to undergo follow-up visits according to the specified time and process of the trial; 2.All subjects who have received injections of XMVA09.
Exclusion criteria
Exclusion criteria: 1. Choroidal neovascularisation (CNV) secondary to diseases other than wAMD in the study eye; 2. Presence of implants (excluding intraocular lens) in the study eye, and turbidity of dioptric media or miosis affecting the fundoscopy in the study eye; 3. Scar, fibrosis, atrophy in fovea centralis in the study eye, or other fundus changes, being clinically significant and affecting the vision of the subject, as assessed by the investigator, in the study eye; 4. Past or current medical history of retinal detachment in the study eye, or other fundus diseases (including vitreous hemorrhage, retinitis pigmentosa, optic neuritis, and retinal vascular disorder; excluding the study indication), being clinically significant and affecting the vision of the subject, as assessed by the investigator, in the study eye; 5. Severe dry eye in the study eye currently on drug therapy, or tear system diseases requiring drug or surgical therapy in the study eye; 6. Uncontrolled (mean intraocular pressure of 3 measurements at screening >21 mmHg) glaucoma and ocular hypertension in the study eye, or optic atrophy, being clinically significant and affecting the vision of the subject, as assessed by the investigator, in the study eye; 7. Other ocular or systemic diseases, being clinically significant and affecting the safety and efficacy evaluation of the subject, as assessed by the investigator; 8. Have intraocular tumor in the study eye currently or within the past 5 years 9. Active eye infection in the study eye or fellow eye; 10. Prior treatment of neovascular age-related macular degeneration (nAMD) in the study eye with drugs (such as sustained-release intravitreal corticosteroid implants and fundus laser therapy) other than anti-VEGF ophthalmic injections within 6 months prior to screening; 11. History of fundus laser treatment in the study eye within 3 months prior to screening; 12. Use of drugs with retinal or lenticular toxicity in the study eye within 6 months prior to screening; 13. Previously treated with local or systemic gene and cellular therapy products or participated in clinical studies of local or systemic gene and cellular therapy products; 14. History of intraocular surgeries in the study eye within 6 months prior to screening; 15. Allergic to or history of allergy to fluorescein sodium or indocyanine green; 16. Allergic to 2 and more drugs and/or non-drug factors; 17. Uncontrolled hypertension after antihypertensive therapy with a blood pressure of SBP/DBP =160/100 mmHg as measured at screening; 18. Poor control of blood glucose (fasting blood glucose > 10.0mmol/L) at screening; 19. Hepatic and renal function test at screening: ALT and AST >2×ULN, or Cr >1.5×ULN, being clinically significant, as assessed by the investigator; 20. Thromboembolic events within 6 months prior to screening; 21. Malignancy history within 5 years prior to screening; 22. Past or current history of systemic autoimmune diseases, or currently on treatment with immunosuppressants or immunostimulants; 23. Active herpes virus infection at screening; 24. Unable to use effective contraception or plan to give birth to a baby during the study; 25. Pregnant or lactating women; 26. Participated in other clinical studies within 3 months prior to screening; 27. Not suitable for the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Dose-limiting toxicity(DLT);Best corrected visual acuity(BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-drug antibody(ADA);Maximum tolerated dose(MTD);Best corrected visual acuity(BCVA);Central Retinal Thickness;Choroidal neovascularization area;CNV leakage area;Total lesion area;Intraretinal and/or subretinal hydrops;Anti-VEGF injection;National eye institute visual function questionnaire-25 (NEI-VFQ-25);Biomarker;Virus shedding;Adverse event and Serious adverse event; | — |
Countries
China
Contacts
Public ContactHua Yan
Tianjin Medical University General Hospital
Outcome results
None listed