Comparative Efficacy and Safety of Biosimilar Bevacizumab (Stivant®) versus Reference Product (Avastin®) in Prethreshold Type I Retinopathy of Prematurity
Why this work is in the frame
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Bibliographic record
Abstract
Purpose: To compare the efficacy and safety of Stivant ® (biosimilar bevacizumab, CinnaGen, Iran) to Avastin ® (innovator bevacizumab, Genentech, South San Francisco, CA) in premature infants with prethreshold type I retinopathy of prematurity (ROP). Methods: Preterm infants with bilateral prethreshold type 1 ROP were enrolled in this nonrandomized contralateral clinical trial. Bilateral intravitreal bevacizumab (IVB) was administered, with Stivant ® injected in one eye and Avastin ® in the other. Patients were followed up weekly for 4 weeks, then biweekly until complete retinal vascularization. Efficacy was evaluated based on disease activity regression (plus disease regression) and complete retinal vascularization. Safety was assessed through the monitoring of adverse events such as uveitis and endophthalmitis. Results: Forty-four infants were included in the study. The mean age at IVB injection was 34.5 weeks. Complete retinal vascularization occurred at a mean age of 60.02 weeks for Stivant ® and 59.93 weeks for Avastin ® ( P = 0.59). Five patients (11.3%) underwent bilateral laser photocoagulation as rescue treatment. Our results showed that Stivant ® was noninferior to Avastin ® in retinal vascularization progress. However, this study cannot make definitive noninferiority claims due to the sample size and its design as a pilot investigation. No cases of endophthalmitis or uveitis were reported. Conclusions: Stivant ® exhibited noninferiority to Avastin ® in efficacy and demonstrated a comparable safety profile in treating prethreshold type I ROP. A definite conclusion requires more extended studies with a larger sample size.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it