Last updated: June 30, 2022
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Macular Degeneration
Geographic Atrophy
Treatment
N/AClinical Study ID
NCT05445063
2021-214
Ages 50-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 50-75 years;
- Clinical diagnosis is consistent with the definition of late dry AMD in theage-related eye disease study (AREDS), with one or more >250 um geographic atrophy inthe fovea;
- Clinical diagnosis is wet AMD, but no obvious efficacy after conventional treatment;
- The BCVA of the target eye will be 0.05 to 0.3;
- Voluntary as test subjects, informed consent, regular follow-up on time.
Exclusion
Exclusion Criteria:
- One-eyed subjects;
- Macular atrophy caused by other diseases in addition to AMD;
- Suffer from retinitis pigmentosa, choroidal retinitis, central serous choroiditis,diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD;
- Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment,optic neuropathy, and other ocular histories;
- Other intraocular surgery histories besides cataract surgery;
- Combined with severe systemic diseases, such as heart failure, liver disease, renalinsufficiency, cor pulmonale, COPD in the previous 12 months;
- Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis,tuberculosis, etc;
- Abnormal blood coagulation function or other laboratory tests;
- If female and of childbearing potential, pregnant, breastfeeding, or planning tobecome pregnant through the study;
- If male, refuse to use barrier and spermicide contraception during the study;
- Malignant tumor and history of malignancy;
- Any immune deficiency;
- Allergy to tacrolimus or other macrolides;
- Any immune deficiency;
- Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3months;
- Use anticoagulant, or the platelet function is still not restored to normal afterstopping antiplatelet drugs for 10 days;
- A history of addiction to alcoholism or prohibited drugs;
- Be participating in other intervention clinical trials or receiving other studymedications;
- Poor compliance, difficulty to complete the study, or refusal to informed consent;
- Some other situations which might increase the risks of the subjects or interfere withclinical trials, such as mental disorders, cognitive dysfunction, etc.
Study Design
Total Participants: 10
Study Start date:
August 01, 2022
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing 100730
ChinaActive - Recruiting
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