VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases (NCT05099094) | Clinical Trial Compass
Active — 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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-related adverse events
Timeframe: At multiple timepoints after infusion up to 12 months.
. 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.
Exclusion criteria
. 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.