Lab-Grown eye cells implanted to fight blindness
NCT ID NCT07418177
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether transplanting lab-grown retinal cells (made from stem cells) into the eye is safe for people with late-stage age-related macular degeneration. Nine participants will receive the cell transplant and be monitored for side effects and any improvement in vision. The goal is to see if this approach can stop or slow further vision loss.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (1)Age ≥50 years and ≤80 years, regardless of gender. * (2)Patients with atrophic AMD in the macular area (geographic atrophy \>250μm, involving the foveal center); or stable non-exudative AMD patients who have undergone treatment for wet AMD or have naturally converted to non-exudative AMD (referring to patients with fibrovascular scar formation, who are unresponsive to anti-VEGF treatment, and have no macular edema on OCT and/or no fluorescein leakage on FFA), with a scar diameter not exceeding 6 PD. * (3)Best-corrected visual acuity (BCVA) of the study eye ≥5 letters and ≤34 letters (using the ETDRS visual acuity chart). * (4)If both eyes meet the criteria, the more severely affected eye will be selected; if the severity is the same in both eyes, the right eye will be designated as the study eye. * (5)The patient or their legal representative has signed a written informed consent form. Exclusion Criteria: * Ocular Diseases: * (1)Vitreous hemorrhage in the study eye within 2 months prior to screening. * (2)Presence of a scar, fibrosis, or atrophy involving the fovea in the study eye, or a peripheral scar area greater than 6 PD, indicating severe irreversible visual loss. * (3)Presence of pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage causing visual loss, rhegmatogenous retinal detachment, macular hole, or choroidal neovascularization due to any cause in the study eye. * (4)Presence of a pupillary block defect (APD) in the study eye. * (5)Significant media opacity in the study eye that may interfere with visual function assessment or fundus examination. * (6)Acute infectious inflammation in either eye during the screening period. * (7)Patients with intraocular pressure higher than 25 mmHg despite medical treatment. * (8)Monocular blind patients. Ocular Treatments: * (9)The study eye has undergone focal/grid laser photocoagulation within 3 months prior to screening. * (10)The study eye has undergone the following intraocular surgeries or laser treatments within 3 months prior to screening, such as macular translocation, cataract surgery, glaucoma filtration surgery, verteporfin photodynamic therapy, transpupillary thermotherapy, foveal laser photocoagulation, vitrectomy, optic nerve decompression, or optic nerve sheath decompression. * (11)Any eye has received anti-angiogenic drug treatment (including any anti-VEGF drugs) within 3 months prior to screening (e.g., Aflibercept \[Eylea®\], Ranibizumab \[Lucentis®\], Bevacizumab \[Avastin®\]). Systemic Diseases, Treatments, and Other Conditions: * (12)Patients with an allergic reaction or history of allergy to sodium fluorescein and indocyanine green, a history of allergy to protein products used for treatment or diagnosis, and patients with allergies to two or more drugs and/or non-drug factors, or those currently suffering from allergic diseases. * (13)Patients with uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L or 2-hour postprandial blood glucose ≥11.1 mmol/L). * (14)Patients with a history of surgical procedures within 1 month prior to screening, or those with unhealed wounds, ulcers, fractures, etc. * (15)Patients with uncontrolled hypertension (defined as a single measurement of systolic blood pressure \>180 mmHg, two consecutive measurements of systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg despite optimal treatment). * (16)Patients with a history of myocardial infarction within 6 months prior to enrollment. * (17)Patients with active disseminated intravascular coagulation or a significant tendency to bleed; patients who have used anticoagulant or antiplatelet aggregation drugs within 14 days prior to screening, except for aspirin/nonsteroidal anti-inflammatory drugs. * (18)Patients with any uncontrollable clinical issues (such as severe psychiatric, neurological, cardiovascular, respiratory, malignant tumors, Parkinson's disease, Alzheimer's disease, and other systemic diseases). * (19)Women of childbearing age with a positive pregnancy test during the screening period. Women who wish to breastfeed during the study period, and all patients of childbearing age (male and female) who do not agree to take effective contraceptive measures (such as intrauterine devices, oral contraceptives, or condoms) throughout the study period and for 30 days after the end of the visit period. * (20)Patients who have participated in or are currently participating in other clinical studies within 30 days prior to screening. * (21)Hemoglobin \<100 g/L, platelets ≤100×109/L, neutrophil count \<1.0×109/L, ALT/AST \>1.5×upper limit of normal (ULN), creatinine \>1.3 mg/dL. * (22)Patients deemed unsuitable for inclusion by the investigator, or other medical conditions that limit the subject's compliance, safety, or affect the results of the study trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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