A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema

Overview

Journal J Clin Med

Specialty General Medicine

Date 2020 Jul 18

PMID 32674280

Citations 6

Authors

Noemi Lois

Evie Gardner

Margaret McFarland

David Armstrong

Christine McNally

Nuala Jane Lavery

Christina Campbell

Rita I Kirk

Daiva Bajorunas

Ann Dunne

Anthony Cerami

Michael Brines

Affiliations

Soon will be listed here.

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.

Citing Articles

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Hartnett M, Fickweiler W, Adamis A, Brownlee M, Das A, Duh E Ophthalmol Sci. 2024; 4(5):100521.

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Neuroinflammation and neurodegeneration in diabetic retinopathy.

Bianco L, Arrigo A, Aragona E, Antropoli A, Berni A, Saladino A Front Aging Neurosci. 2022; 14:937999.

PMID: 36051309 PMC: 9424735. DOI: 10.3389/fnagi.2022.937999.

State-of-the-Art Research on Diabetic Retinopathy.

Simo R J Clin Med. 2022; 11(13).

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Recent Advancements in the Medical Treatment of Diabetic Retinal Disease.

Szymanska M, Mahmood D, Yap T, Cordeiro M Int J Mol Sci. 2021; 22(17).

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Cibinetide Protects Isolated Human Islets in a Stressful Environment and Improves Engraftment in the Perspective of Intra Portal Islet Transplantation.

Yao M, Domogatskaya A, Agren N, Watanabe M, Tokodai K, Brines M Cell Transplant. 2021; 30:9636897211039739.

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