Oliva Azalia Putri
Department of Surgery, CMHC Research Center, Palembang, Indonesia

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Sustained Anti-VEGF Delivery via Hydrogel Implant Achieves Non-Inferior Visual and Anatomical Outcomes in Neovascular AMD: A 24-Month Randomized Controlled Trial Habiburrahman Said; Oliva Azalia Putri; Linda Purnama
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.v8i2.138

Abstract

Introduction: Neovascular age-related macular degeneration (nAMD) requires frequent anti-VEGF intravitreal injections, creating substantial treatment burden. This study compared the 24-month efficacy and safety of a sustained-release anti-VEGF hydrogel implant versus monthly ranibizumab in treatment-naive nAMD eyes. Methods: This prospective randomized controlled trial enrolled 126 eyes (96 patients; 30 bilateral) with treatment-naive nAMD at a private hospital in Palembang, Indonesia (January 2022–December 2024). Eyes were randomized 1:1 to a biodegradable anti-VEGF hydrogel implant (n=64) or monthly ranibizumab 0.5 mg (n=62). The primary outcome was non-inferiority of the mean best-corrected visual acuity (BCVA) change (LogMAR) at 24 months (margin: 0.10 LogMAR). Analyses used linear mixed-effects models with generalized estimating equations to account for inter-eye correlation. Results: Mean BCVA improved by −0.24±0.18 LogMAR (≈12 letters) in the hydrogel group and −0.22±0.20 LogMAR (≈11 letters) in the ranibizumab group (difference: −0.02; 95% CI: −0.09 to 0.05; p=0.578; non-inferiority confirmed). The hydrogel group required 77.8% fewer injections (4.8±1.2 vs 21.6±3.4; p<0.001). Safety profiles were comparable. Conclusion: The sustained-release anti-VEGF hydrogel implant achieved non-inferior visual and anatomical outcomes versus monthly ranibizumab while reducing injection burden by 77.8% over 24 months. Multicenter validation is 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.
Sustained Anti-VEGF Delivery via Hydrogel Implant Achieves Non-Inferior Visual and Anatomical Outcomes in Neovascular AMD: A 24-Month Randomized Controlled Trial Habiburrahman Said; Oliva Azalia Putri; Linda Purnama
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.v8i2.138

Abstract

Introduction: Neovascular age-related macular degeneration (nAMD) requires frequent anti-VEGF intravitreal injections, creating substantial treatment burden. This study compared the 24-month efficacy and safety of a sustained-release anti-VEGF hydrogel implant versus monthly ranibizumab in treatment-naive nAMD eyes. Methods: This prospective randomized controlled trial enrolled 126 eyes (96 patients; 30 bilateral) with treatment-naive nAMD at a private hospital in Palembang, Indonesia (January 2022–December 2024). Eyes were randomized 1:1 to a biodegradable anti-VEGF hydrogel implant (n=64) or monthly ranibizumab 0.5 mg (n=62). The primary outcome was non-inferiority of the mean best-corrected visual acuity (BCVA) change (LogMAR) at 24 months (margin: 0.10 LogMAR). Analyses used linear mixed-effects models with generalized estimating equations to account for inter-eye correlation. Results: Mean BCVA improved by −0.24±0.18 LogMAR (≈12 letters) in the hydrogel group and −0.22±0.20 LogMAR (≈11 letters) in the ranibizumab group (difference: −0.02; 95% CI: −0.09 to 0.05; p=0.578; non-inferiority confirmed). The hydrogel group required 77.8% fewer injections (4.8±1.2 vs 21.6±3.4; p<0.001). Safety profiles were comparable. Conclusion: The sustained-release anti-VEGF hydrogel implant achieved non-inferior visual and anatomical outcomes versus monthly ranibizumab while reducing injection burden by 77.8% over 24 months. Multicenter validation is warranted.