Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Safety and Effectiveness of subretinal injection of NGGT001 for treating crystalline retinal degeneration
Xiuju Chen
Xiamen, Fujian, China
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 1 year
Change from baseline in best-corrected visual acuity
Best-corrected visual acuity will be measured using Early Treatment Diabetic Retinopathy Study visual acuity charts and reported as the ETDRS letter score. Change from baseline will be calculated separately for the treated study eye and the untreated nonstudy eye. A positive change from baseline indicates improvement in visual acuity.
Time frame: Baseline and Months 1, 2, 3, 4, 5, 6, 9, and 12; the primary efficacy assessment is the change from baseline at Month 12.
Change from baseline in retinal sensitivity assessed by microperimetry
Retinal sensitivity will be assessed using the MP-3 microperimeter (Nidek) and reported in decibels. Change from baseline in retinal sensitivity will be calculated separately for the treated study eye and the untreated nonstudy eye. A positive change from baseline indicates increased retinal sensitivity.
Time frame: Baseline to Month 12
Change from baseline in contrast sensitivity
Contrast sensitivity will be assessed under mesopic conditions using a sine-wave grating-based system (Metrovision) at spatial frequencies of 0.8, 1.6, 3.2, 6.4, 12.8, and 25.6 cycles per degree. Contrast sensitivity will be reported in decibels. Change from baseline will be calculated separately for the treated study eye and the untreated nonstudy eye. A positive change from baseline indicates improvement in contrast sensitivity.
Time frame: From baseline at Month 12
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