VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases

NCT05099094 | Active Not Recruiting Early Phase 1

• 1 other identifier: BD311
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Keywords

Retinal diseases; Choroidal diseases; Neovascularization; nAMD; neovascular age-related macular degeneration; DME; Diabetic macular edema; RVO-ME; Retinal vein occlusion-Macular edema

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Changes in macular intraretinal fluid (IRF)

  At multiple timepoints after infusion up to 12 months.

• Changes in subretinal fluid (SRF)

  At multiple timepoints after infusion up to 12 months.

• Change in central retinal thickness (CRT)

  At multiple timepoints after infusion up to 12 months.

• Changes in the area of choroidal neovascularization

  At multiple timepoints after infusion up to 12 months.

• Changes in the area of fluorescein leakage

  At multiple timepoints after infusion up to 12 months.

Study Arms (1)

BD311 Adults single group

EXPERIMENTAL

Administered by suprachoroidal injection. Dosage form: injection solution. Dose: 500uL. Frequency of administration: one time injection.

Genetic: BD311

Interventions

BD311 GENETIC

Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody

BD311 Adults single group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with nAMD at the age ≥50; Or patients with diabetic macular edema (DME) at the age ≥18; Or patients with macular edema following retinal vein occlusion (RVO-ME) at the age ≥18.
• Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity ≤63 and letter score ≥19 Corresponding Snellen vision ≤20/63 and ≥20/400).
• OCT confirms the presence of intraretinal fluid or subretinal fluid in the fovea.
• Have received anti-VEGF therapy in the past and have responded to anti-VEGF therapy.
• 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)
• For patients with both eyes suffered, enroll the one with more severe condition.
• Routine blood test, liver and kidney function, coagulation index of patients is normal：AST/ALT \< 2.5 × ULN; TB \< 1.5 × ULN; PT \< 1.5 × ULN; Hb \> 10 g/dL (male) and \> 9 g/dL (female); PLT \> 100 × 10\^3/µL; eGFR \> 30 mL/min/1.73 m\^2.
• Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Choroidal neovascularization or macular edema induced by other diseases.
• Any other factors that affect vision improvement in the study eye, such as fibrosis, atrophy, or RPE tear in the fovea of the macula.
• The study eye already has severe proliferative retinopathy, such as retinal neovascularization, traction retinal detachment, etc. (only for DME and RVO-ME patients) .
• Retinal detachment or advanced glaucoma in the study eye.
• Implants in the study eye (except intraocular lenses).
• Received internal eye surgery within 3 months prior to enrollment.
• Vitrectomy surgery on the study eye.
• Received intravitreal glucocorticoid or other clinical research drugs (except anti-VEGF therapy) within 6 months prior to enrollment.
• Myocardial infarction, cerebrovascular accident or transient ischemic attack occurred within 6 months prior to enrollment.
• Poorly controlled hypertension under maximum medication (systolic blood pressure\>180 mmHg, diastolic blood pressure\>100 mmHg).
• Poor blood glucose control under medication (fasting blood glucose is greater than or equal to 10.0 umol/L).
• Women who are willing to give birth; pregnant/breastfeeding women Have received gene therapy in the past.

Sponsors & Collaborators

• Shanghai BDgene Co., Ltd.: lead
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, SH, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 36912792 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion; Retinal Diseases; Choroid Diseases; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Uveal Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gezhi Xu, Dr

  Eye & ENT Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 29, 2021
• Study Start: November 25, 2021
• Primary Completion: November 30, 2024
• Study Completion: September 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)