Objective:
To evaluate the efficacy and safety of adjunctive intravitreal methotrexate (ADX-2191) in reducing postoperative complications in proliferative vitreoretinopathy (PVR) surgery, focusing on the primary endpoint of reoperation rates.
Key Findings:
- 24% reoperation rate in the ADX-2191 group compared to 39% in historical controls (P=.024), indicating statistical significance.
- Significantly fewer cases of hypotony and cystoid macular edema in the ADX-2191 group.
- Most common adverse event was mild to moderate punctate keratitis (16% incidence).
Interpretation:
Routine surgical care with ADX-2191 showed numerical superiority in reducing postoperative complications, although the study was underpowered for some comparisons, limiting the strength of the conclusions.
Limitations:
- The study was underpowered to detect statistically significant differences in reoperation rates.
- Enrollment issues in the control arm affected the robustness of the findings.
- Using historical controls may introduce bias and limit the generalizability of the results.
Conclusion:
ADX-2191 demonstrated a favorable safety profile and reduced postoperative complications in PVR surgery, warranting further investigation.
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