Study summary · research use only
A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This phase 2 clinical trial in human patients with diabetic macular edema (DME) evaluated the peptide cibinetide, self-administered subcutaneously over several weeks. Patients were recruited from a single site, with the study eye chosen as the one with better vision and lower central retinal thickness (CRT) at baseline. No improvement was found in mean best corrected visual acuity (BCVA), CRT, central retinal sensitivity, or tear production, but an improvement was described in composite scores on the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Some participants showed improvements in CRT, tear production, diabetic control, and albuminuria. No serious adverse events or anti-cibinetide antibodies were observed; the authors state these mixed findings warrant further investigation.
Abstract
Evaluating the effects of cibinetide in diabetic macular edema (DME). Phase 2 trial. Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust. The study eye was that with best vision and lowest CRT. Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks. Primary and secondary outcomes: mean change from baseline to week 12 in best corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide. Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria. Nine patients were recruited; eight completed the study. There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1). Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria. No serious adverse events/reactions or anti-cibinetide antibodies were seen. The cibinetide 12-week course was safe. Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation. EudraCT number: 2015-001940-12. ISRCTN16962255-registration date 25.06.15.
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