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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06302608
Other study ID # NGGT-BCD-P-2203
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date February 8, 2023
Est. completion date May 29, 2028

Study information

Verified date February 2024
Source Xiamen Ophthalmology Center Affiliated to Xiamen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6
Est. completion date May 29, 2028
Est. primary completion date May 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years old; 2. Gender unlimited. 3. Diagnosed as crystalline retinal degeneration (BCD). 4. Molecular diagnosis confirms CYP4V2 mutation. 5. The best corrected visual acuity is less than 20/60. 6. Agree to take contraceptive measures within 1 year from the start of the study until administration. 7. Voluntarily sign an informed consent form. Exclusion Criteria: 1. Insufficient number of photoreceptor cells in the retina, such as retinal thickness less than 100 ยต m. Or no atrophy or pigmentation in the posterior pole area<3- Retinal disc. 2. The presence of choroidal neovascularization or other eye lesions caused by BCD, which researchers believe may affect surgical procedures or interfere with the interpretation of clinical endpoints. 3. The use of therapeutic drugs within the first 6 months of enrollment may affect experimental observation, such as Lucentis, Avastin, Conbercept, Triamcinolone acetonide, steroids, etc; 4. The treatment eye has undergone intraocular surgery, such as PDT, vitrectomy, periocular vascular bypass surgery, etc., or requires intraocular surgery during clinical research, such as cataract surgery, retinal laser therapy, etc; 5. Used or may use systemic medications that may cause eye damage, such as psoralen, tamoxifen, etc; 6. Highly sensitive or allergic to the ingredients in the experimental drug (with a history of allergies to two or more drugs or foods); 7. Abnormal and clinically significant physical examination, vital signs, laboratory tests (such as blood routine, urine routine, blood biochemistry, coagulation function, immunological tests, etc.), or abnormal indicators deemed clinically significant by researchers; 8. There are diseases or medical histories that may affect drug safety or internal processes, especially cardiovascular, liver, kidney, endocrine, digestive, lung, neurological, hematological, tumor, immune or metabolic disorders that researchers consider clinically significant. 9. Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment; 10. Female patients during pregnancy or lactation; 11. Other researchers believe that it is not suitable to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
NGGT001
Safety and Effectiveness of subretinal injection of NGGT001 for treating crystalline retinal degeneration

Locations

Country Name City State
China Xiuju Chen Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
Xiamen Ophthalmology Center Affiliated to Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary BCVA ETDRS visual acuity 1 year
Primary Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) 1 year
See also
  Status Clinical Trial Phase
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Recruiting NCT05832684 - Safety and Efficacy of ZVS101e in Patients With Bietti 's Crystalline Dystrophy Phase 1/Phase 2
Recruiting NCT04722107 - Safety Study of rAAV2/8-hCYP4V2 in Patients With Bietti's Crystalline Dystrophy (BCD) Early Phase 1