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

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

doi:10.3390/jcm9072225

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

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

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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.

Original language	English
Journal	Journal of Clinical Medicine
Volume	9
Issue number	7
DOIs	https://doi.org/10.3390/jcm9072225
Publication status	Published - 14 Jul 2020

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A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema
Copyright 2020 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
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title = "A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema",

abstract = "PURPOSE: Evaluating the effects of cibinetide in diabetic macular edema (DME).METHODS: Phase 2 trial. Na{\"i}ve 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.",

author = "Noemi Lois and Evie Gardner and Margaret McFarland and David Armstrong and Christine McNally and Lavery, {Nuala Jane} and Christina Campbell and Kirk, {Rita I} and Daiva Bajorunas and Ann Dunne and Anthony Cerami and Michael Brines",

year = "2020",

month = jul,

day = "14",

doi = "10.3390/jcm9072225",

language = "English",

volume = "9",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

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T1 - A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema

AU - Lois, Noemi

AU - Gardner, Evie

AU - McFarland, Margaret

AU - Armstrong, David

AU - McNally, Christine

AU - Lavery, Nuala Jane

AU - Campbell, Christina

AU - Kirk, Rita I

AU - Bajorunas, Daiva

AU - Dunne, Ann

AU - Cerami, Anthony

AU - Brines, Michael

PY - 2020/7/14

Y1 - 2020/7/14

N2 - 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.

AB - 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.

U2 - 10.3390/jcm9072225

DO - 10.3390/jcm9072225

M3 - Article

C2 - 32674280

VL - 9

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

SN - 2077-0383

IS - 7

ER -

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

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