Renal Safety of Intravitreal Ranibizumab and the Effects of SGLT2 Inhibition in Diabetic Macular Oedema: A Post Hoc Analysis of the COMET Trial.
Toshiki Sakai, Ryoichi Ishibashi, Masaya Koshizaka et al.
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In 30 seconds
This post hoc analysis of the prospective COMET randomised controlled trial examined whether intravitreal ranibizumab (IVR) exposure was associated with renal markers in 53 participants with diabetic macular oedema, and whether SGLT2 inhibition showed expected systemic effects. Over 48 weeks, cumulative IVR was not significantly associated with eGFR, urinary albumin-to-creatinine ratio, or haematocrit. For eGFR, the estimate was -0.22 mL/min/1.73 m² per injection (95% CI -0.59 to 0.15; p = 0.25). SGLT2 inhibition was associated with an early eGFR dip and a rise in haematocrit.
Key findings
- Cumulative IVR was not significantly associated with eGFR: -0.22 mL/min/1.73 m² per injection (95% CI -0.59 to 0.15; p = 0.25).
- No significant association was detected between cumulative IVR and ln(UACR) or haematocrit.
- SGLT2 inhibition reproduced an early eGFR dip and a haematocrit rise.
Why it matters
These findings provide renal-marker data for patients receiving intravitreal ranibizumab for diabetic macular oedema, while also showing expected systemic marker changes with SGLT2 inhibition. The absence of a detected exposure-response association is reassuring within the studied cohort and dosing range, but does not establish that cumulative renal effects are absent.
What to keep in mind
The analysis was post hoc and included a modest sample. All participants received IVR, and the authors note that small cumulative renal effects cannot be excluded.