Status:
RECRUITING
CRISPR/cas13-medIated RNA TarGeting THerapy for the Treatment of Neovascular Age-related Macular Degeneration Investigator-initiated Trial (SIGHT-I)
Lead Sponsor:
HuidaGene Therapeutics Co., Ltd.
Collaborating Sponsors:
Tianjin Medical University Eye Hospital
Eye & ENT Hospital of Fudan University
Conditions:
Neovascular Age-related Macular Degeneration(nAMD)
Eligibility:
All Genders
50-80 years
Phase:
EARLY_PHASE1
Brief Summary
Age-related macular degeneration (AMD) is a progressive disease leading to severe and irreversible vision loss of which the neovascular AMD (nAMD) accounted for 90% blindness in AMD. nAMD is primarily...
Eligibility Criteria
Inclusion
- Males or females ≥ 50 and ≤ 80 years at the time of signing the ICF
- Diagnosed of choroidal neovascularization (CNV) secondary to AMD in the study eye;
- Best-corrected visual acuity (BCVA) ranged from 73 to 23 early treatment diabetic retinopathy study (ETDRS)letter score (corresponding to 20/32 to 20/320 of Snellen visual acuity) in the study eye;
- BCVA in the non-study eye had an ETDRS letter score of 19(equivalent to Snellen visual acuity20/400) and above;
- Able to perform visual acuity and retinal function tests and able and willing to comply with study procedures for this clinical trial;
- RESPONSIVE SUBJECTS:
- History of need for and responsive to anti-VEGF therapy in the study eye
- NON-RESPONSIVE SUBJECTS:
- History of receiving anti-VEGF therapy but is resistant to treatment, which is defined as: a. complete or near-complete remission of subretinal fluid after the initial 3 doses of anti-VEGF agents and thenno improvement (less than 50um reduction) or deterioration of CRT by OCT
Exclusion
- Subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesion in the study eye;
- Any condition in the Investigator's opinion that could limit visual improvement in the study eye;
- Other ocular diseases that may affect central vision in the study eye (e.g., retinal vein occlusion, retinal detachment, macular hole, optic nerve disease, etc.);
- Presence of CNV not due to nAMD in the study eye,
- Uncontrolled glaucoma in the study eye;
- Active intraocular inflammation or a history of uveitis in either eye;
- History or presence of corneal dystrophy in the study eye;
- Subjects with immunodeficiency diseases prone to opportunistic infections;
- History of other intraocular surgery in the study eye within 3 months prior to baseline that in the Investigator's opinion could impact healing or study outcome interpretation;
- Prior gene therapy or oligonucleotide therapy;
- History of acute coronary syndrome, myocardial infarction, coronary revascularization, cerebrovascular accident, or transient ischemic attack within 6 months prior to the Screening Visit;
- Other conditions judged by the investigator as inappropriate for the study.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06031727
Start Date
September 4 2023
End Date
June 30 2026
Last Update
March 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
2
Tianjin Medical University Eye Hospital
Tianjin, Tianjing, China