VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases (NCT05099094) | Clinical Trial Compass
Active β Not RecruitingEarly Phase 1
VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases
China3 participantsStarted 2021-11-25
Plain-language summary
Patients who respond to anti-VEGF therapy but with refractory retinal and choroidal neovascularization diseases including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion-Macular edema (RVO-ME).
Who can participate
Age range18 Years β 80 Years
SexALL
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Inclusion criteria
β. Patients with nAMD at the age β₯50; Or patients with diabetic macular edema (DME) at the age β₯18; Or patients with macular edema following retinal vein occlusion (RVO-ME) at the age β₯18.
β. Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity β€63 and letter score β₯19 Corresponding Snellen vision β€20/63 and β₯20/400).
β. OCT confirms the presence of intraretinal fluid or subretinal fluid in the fovea.
β. Have received anti-VEGF therapy in the past and have responded to anti-VEGF therapy.
β. With refractory conditions: repeated anti-VEGF treatments are required due to the disease condition. When the treatment is interrupted, the disease condition recurs (OCT examination indicates increased subretinal/inner effusion in the macula)
β. For patients with both eyes suffered, enroll the one with more severe condition.
β. Routine blood test, liver and kidney function, coagulation index of patients is normalοΌAST/ALT \< 2.5 Γ ULN; TB \< 1.5 Γ ULN; PT \< 1.5 Γ ULN; Hb \> 10 g/dL (male) and \> 9 g/dL (female); PLT \> 100 Γ 10\^3/Β΅L; eGFR \> 30 mL/min/1.73 m\^2.
Exclusion criteria
β. Choroidal neovascularization or macular edema induced by other diseases.
β. Any other factors that affect vision improvement in the study eye, such as fibrosis, atrophy, or RPE tear in the fovea of the macula.
β. The study eye already has severe proliferative retinopathy, such as retinal neovascularization, traction retinal detachment, etc. (only for DME and RVO-ME patients) .
What they're measuring
1
Treatment-related adverse events
Timeframe: At multiple timepoints after infusion up to 12 months.