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All Journal Sriwijaya Journal of Ophthalmology Sriwijaya Journal of Radiology and Imaging Research
Sony Sanjaya
Department of Medical Biology, CMHC Research Center, Palembang, Indonesia
Biochemistry, Genetics & Molecular Biology Dentistry Health Professions Medicine & Pharmacology Neuroscience Physics

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Safety and Efficacy of Subretinal AAV-CRISPR/Cas9 Gene Editing for Rhodopsin-Mutant Retinitis Pigmentosa: A Phase I/IIa Dose-Escalation Triall Khairiel Anwar; Sony Sanjaya; Rizky Ayu; Fachruddin Sani
Sriwijaya Journal of Ophthalmology Vol. 8 No. 2 (2025): Sriwijaya Journal of Ophthalmology
Publisher : Department of Opthalmology, Faculty of Medicine, Universitas Sriwijaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/sjo.v8i2.137

Abstract

Introduction: Autosomal dominant retinitis pigmentosa (adRP) from rhodopsin (RHO) mutations lacks an approved gene therapy. This Phase I/IIa trial evaluated subretinal AAV5-CRISPR/Cas9 for RHO-adRP. Methods: An open-label, 3+3 dose-escalation design with expansion at the recommended Phase II dose (RP2D) was used. Eighteen patients (18 study eyes; one eye per patient) received subretinal AAV5-CRISPR/Cas9 at low (1.5×1010 vg, n = 3), mid (5.0×1010 vg, n = 3), or high (1.5×1011 vg, n = 6) doses, plus an expansion cohort (n = 6) at RP2D, at a private hospital in Palembang, Indonesia. The primary endpoint was dose-limiting toxicities (DLTs); secondary endpoints were BCVA (LogMAR), SD-OCT ellipsoid zone (EZ) width, microperimetry, and ffERG. Results: No DLTs occurred. The high-dose cohort showed a BCVA improvement of −0.14 LogMAR (95% CI −0.22 to −0.06, p = 0.003; Cohen d = 1.82), an EZ width increase of +312 µm (95% CI +187 to +437, p < 0.001; d = 2.45), and a microperimetry gain of +3.8 dB (95% CI +2.1 to +5.5, p < 0.001; d = 1.94). Dose-response trends were significant (Jonckheere–Terpstra p-trend: BCVA 0.008, EZ 0.002). Conclusion: Subretinal AAV5-CRISPR/Cas9 demonstrated acceptable safety with dose-dependent structural and functional improvements at 12 months. Phase II/III trials are warranted.
Deep-Learning Pharmacokinetic Modelling for Personalised Low-Dose Gadolinium in Oncological 3.0-T MRI: A Diagnostic-Accuracy Study Oliva Azalia Putri; Sony Sanjaya
Sriwijaya Journal of Radiology and Imaging Research Vol. 3 No. 2 (2025): Sriwijaya Journal of Radiology and Imaging Research
Publisher : Phlox Institute: Indonesian Medical Research Organization

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.59345/sjrir.v3i2.290

Abstract

Introduction: Weight-based dosing of gadolinium-based contrast agents (GBCA; 0.1 mmol/kg) in oncological MRI disregards individual haemodynamics and tumour microvascularity, contributing to avoidable cumulative exposure and tissue-retention risk. We evaluated an artificial-intelligence (AI)-assisted pharmacokinetic-modelling approach to personalise and reduce GBCA dose while preserving diagnostic performance. Methods: In this prospective, paired diagnostic-accuracy study reported per STARD 2015 at a tertiary hospital in Palembang, Indonesia, 152 adults (198 lesions) with histologically confirmed solid primary malignancies underwent 3.0-T contrast-enhanced MRI. A convolutional-neural-network extended-Tofts model derived each patient’s minimum effective gadobutrol dose, compared against the standard 0.1 mmol/kg protocol. Two radiologists, blinded to clinical data and to a composite reference standard (histopathology and ≥6-month imaging follow-up), assessed signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), 5-point diagnostic confidence and lesion characterisation. Sensitivity, specificity, AUC (DeLong), likelihood ratios, Cohen’s κ and McNemar testing were computed with 95% confidence intervals. Results: The AI protocol reduced GBCA dose by 38.4% (4.6 vs 7.5 mL; p<0.001). Sensitivity was 95.2% (95% CI 90.9–97.6), specificity 83.3% (66.4–92.7) and AUC 0.94 (0.90–0.97) versus 0.95 (0.91–0.98) for standard dose (DeLong p=0.620; McNemar p=0.773). SNR and CNR were non-inferior (all p>0.05). Inter-reader agreement was substantial-to-almost-perfect (characterisation κ 0.83; confidence κ 0.88). Diagnostic adequacy was maintained in 149/152 cases (98%). Conclusion: AI-assisted pharmacokinetic modelling enabled a 38% gadolinium-dose reduction without loss of diagnostic accuracy or image quality, supporting personalised contrast administration and lower cumulative exposure in oncological MRI.
Safety and Efficacy of Subretinal AAV-CRISPR/Cas9 Gene Editing for Rhodopsin-Mutant Retinitis Pigmentosa: A Phase I/IIa Dose-Escalation Triall Khairiel Anwar; Sony Sanjaya; Rizky Ayu; Fachruddin Sani
Sriwijaya Journal of Ophthalmology Vol. 8 No. 2 (2025): Sriwijaya Journal of Ophthalmology
Publisher : Department of Ophthalmology, Faculty of Medicine, Universitas Sriwijaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/sjo.v8i2.137

Abstract

Introduction: Autosomal dominant retinitis pigmentosa (adRP) from rhodopsin (RHO) mutations lacks an approved gene therapy. This Phase I/IIa trial evaluated subretinal AAV5-CRISPR/Cas9 for RHO-adRP. Methods: An open-label, 3+3 dose-escalation design with expansion at the recommended Phase II dose (RP2D) was used. Eighteen patients (18 study eyes; one eye per patient) received subretinal AAV5-CRISPR/Cas9 at low (1.5×1010 vg, n = 3), mid (5.0×1010 vg, n = 3), or high (1.5×1011 vg, n = 6) doses, plus an expansion cohort (n = 6) at RP2D, at a private hospital in Palembang, Indonesia. The primary endpoint was dose-limiting toxicities (DLTs); secondary endpoints were BCVA (LogMAR), SD-OCT ellipsoid zone (EZ) width, microperimetry, and ffERG. Results: No DLTs occurred. The high-dose cohort showed a BCVA improvement of −0.14 LogMAR (95% CI −0.22 to −0.06, p = 0.003; Cohen d = 1.82), an EZ width increase of +312 µm (95% CI +187 to +437, p < 0.001; d = 2.45), and a microperimetry gain of +3.8 dB (95% CI +2.1 to +5.5, p < 0.001; d = 1.94). Dose-response trends were significant (Jonckheere–Terpstra p-trend: BCVA 0.008, EZ 0.002). Conclusion: Subretinal AAV5-CRISPR/Cas9 demonstrated acceptable safety with dose-dependent structural and functional improvements at 12 months. Phase II/III trials are warranted.
Co-Authors Fachruddin Sani Khairiel Anwar Oliva Azalia Putri Rizky Ayu