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).
Choroidal and retinal angiogenesis diseases are a group of diseases characterized by choroidal or retinal angiogenesis. These diseases are often correlated with the macular area, which may lead to significant visual loss. In this study, The IDLV vector is engineered to carry the VEGFA antibody gene. The gene is delivered to the RPE cells to express the VEGFA antibody which neutralizes the VEGFA activity in the posterior segment of the eye of individuals who have progressed to various forms of neovascular macular degeneration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody
Eye & ENT Hospital of Fudan University
Shanghai, SH, China
Treatment-related adverse events
Observe and record incidences of AE and SAE related to VEGFA-targeting gene therapy drug BD311 (IDLV expressing VEGFA antibody) administration.
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in macular intraretinal fluid (IRF)
The presence of macular intraretinal fluid (IRF) will be determined by optical coherence tomography (OCT).
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in subretinal fluid (SRF)
The presence of subretinal fluid (SRF) will be determined by optical coherence tomography (OCT).
Time frame: At multiple timepoints after infusion up to 12 months.
Change in central retinal thickness (CRT)
Central retinal thickness will be measured by Optical Coherence Tomography (OCT).
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in the area of choroidal neovascularization
Using Fluorescein angiography (FFA) and indocyanine green angiography (ICGA) to assess the areas of choroidal neovascularization. Only for patients with nAMD.
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in the area of fluorescein leakage
Using Fluorescein angiography (FFA) and indocyanine green angiography (ICGA) to assess the areas of fluorescein leakage. Only for patients with nAMD.
Time frame: At multiple timepoints after infusion up to 12 months.
The number of rescue treatments
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Rescue treatments that require vitreous anti-VEGF injections due to illness.
Time frame: At multiple timepoints after infusion up to 12 months.
Evaluate the visual improvement
Subjects will be examined for best corrected visual acuity (BCVA).
Time frame: At multiple timepoints after infusion up to 12 months.