Neovascular Age-related Macular DegenerationEarly Phase 1NCT05099094
VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases
A Early Phase 1 study testing BD311 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Shanghai BDgene Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- BD311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2021to Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Study of VEGFA-targeting Gene Therapy to Treat Refractory Retinal and Choroidal Neovascularization Diseases
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).
Read the detailed description
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.
- Conditions
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- Being tested
- BD311
- Keywords
- Retinal diseases, Choroidal diseases, Neovascularization, nAMD, neovascular age-related macular degeneration, DME, Diabetic macular edema, RVO-ME, Retinal vein occlusion-Macular edema
- Medical subject headings
- Retinal Vein Occlusion, Retinal Diseases, Choroid Diseases, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD311Genetic
Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody
| Study group | Role | What they receive |
|---|---|---|
| BD311 Adults single group | Experimental | Administered by suprachoroidal injection. Dosage form: injection solution. Dose: 500uL. Frequency of administration: one time injection. Receives: Genetic: BD311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At multiple timepoints after infusion up to 12 months.
Secondary outcomes (7)
Changes in macular intraretinal fluid (IRF)
The presence of macular intraretinal fluid (IRF) will be determined by optical coherence tomography (OCT).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At multiple timepoints after infusion up to 12 months.
Evaluate the visual improvement
Subjects will be examined for best corrected visual acuity (BCVA).
Measured: At multiple timepoints after infusion up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start25 Nov 2021
- Primary completion30 Nov 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai BDgene Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Gezhi Xu, Dr, Study director, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099094
- Sponsor's protocol ID
- BD311
- Status last verified
- Jun 2024
- First submitted
- 18 Sep 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36912792
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of VEGFA-targeting Gene Therapy to Treat Refractory Retinal and Choroidal Neovascularization Diseases
- ClinicalTrials.gov ID
- NCT05099094
- Acronym / sponsor ID
- BD311
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Shanghai BDgene Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD311 Adults single group | Experimental | Genetic: BD311Administered by suprachoroidal injection. Dosage form: injection solution. Dose: 500uL. Frequency of administration: one time injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD311Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody | Genetic | BD311 Adults single group |
Primary outcome
Treatment-related adverse events
Time frame: At multiple timepoints after infusion up to 12 months.
Observe and record incidences of AE and SAE related to VEGFA-targeting gene therapy drug BD311 (IDLV expressing VEGFA antibody) administration.
7 secondary outcomes
Changes in macular intraretinal fluid (IRF)
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in subretinal fluid (SRF)
Time frame: At multiple timepoints after infusion up to 12 months.
Change in central retinal thickness (CRT)
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in the area of choroidal neovascularization
Time frame: At multiple timepoints after infusion up to 12 months.
Changes in the area of fluorescein leakage
Time frame: At multiple timepoints after infusion up to 12 months.
The number of rescue treatments
Time frame: At multiple timepoints after infusion up to 12 months.
Evaluate the visual improvement
Time frame: At multiple timepoints after infusion up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 36912792Romano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gezhi Xu, Dr study director
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BD311 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Shanghai BDgene Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: At multiple timepoints after infusion up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.