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| Name | Class |
|---|---|
| Eye & ENT Hospital of Fudan University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BD311 Adults single group | Experimental | Administered by suprachoroidal injection. Dosage form: injection solution. Dose: 500uL. Frequency of administration: one time injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD311 | Genetic | Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At multiple timepoints after infusion up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in macular intraretinal fluid (IRF) | The presence of macular intraretinal fluid (IRF) will be determined by optical coherence tomography (OCT). | At multiple timepoints after infusion up to 12 months. |
| Changes in subretinal fluid (SRF) |
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Inclusion Criteria:
Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gezhi Xu, Dr | Eye & ENT Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | SH | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912792 | Derived | Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14. |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D012164 | Retinal Diseases |
| D015862 | Choroid Diseases |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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The presence of subretinal fluid (SRF) will be determined by optical coherence tomography (OCT).
| 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). | 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. | 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. | At multiple timepoints after infusion up to 12 months. |
| The number of rescue treatments | Rescue treatments that require vitreous anti-VEGF injections due to illness. | At multiple timepoints after infusion up to 12 months. |
| Evaluate the visual improvement | Subjects will be examined for best corrected visual acuity (BCVA). | At multiple timepoints after infusion up to 12 months. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014603 | Uveal Diseases |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |