Abstract
Purpose: Evaluating the effects of cibinetide in diabetic macular edema (DME). Methods: 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. Results: 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. Conclusions: 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. Trial Registration: EudraCT number: 2015-001940-12. ISRCTN16962255—registration date 25.06.15.
Highlights
Diabetic macular edema (DME) is a leading cause of sight loss in people with diabetes with an estimated overall age-standardised prevalence of 6.8% [1]
Cibinetide was safe when administered to patients with DME
When evaluating individual participant data, improvements in central retinal thickness (CRT) and tear production were seen in some individuals
Summary
Diabetic macular edema (DME) is a leading cause of sight loss in people with diabetes with an estimated overall age-standardised prevalence of 6.8% [1]. DME can be treated with laser, anti-vascular endothelial growth factor (anti-VEGF) therapies or steroids. Randomised clinical trials (RCTs) have shown efficacy of anti-VEGFs; their route (intravitreal) and frequency (monthly initially and still frequently thereafter) of administration, requirement of long-term treatment (40–50% of patients require injections at 4–5 years following initiation) and of additional therapies to control DME (~50% of patients on anti-VEGFs still require laser treatment), potential complications (increased intraocular pressure, cataract, retinal detachment, endophthalmitis) and cost are important shortcomings [2,3,4]. IRR signalling activates an anti-inflammatory-reparative response, from macrophage/microglial populations, endothelial cells, and neurons. These activities include the powerful attenuation of tissue-damaging pro-inflammatory cytokines, preservation of the BRB, and prevention of neuronal and endothelial cell apoptosis, among others [8]. It is possible that this peptide could have a beneficial effect on the treatment of DR and DME and warrants investigation
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
