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Study · Non-randomized trial · n = 9 · 2020

8 results

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

Lois N, Gardner E, McFarland M, Armstrong D, McNally C, Lavery NJ, Campbell C, Kirk RI, Bajorunas D, Dunne A, Cerami A, Brines M

Journal of clinical medicine14 Jul 2020Cited by 9 (Europe PMC)

PMID32674280 (opens in a new tab)PMCIDPMC7408632 (opens in a new tab)DOI10.3390/jcm9072225 (opens in a new tab)PepBankPUB-32674280
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Summary

PurposeEvaluating the effects of cibinetide in diabetic macular edema (DME).MethodsPhase 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.ResultsNine 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.ConclusionsThe 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 registrationEudraCT number: 2015-001940-12. ISRCTN16962255-registration date 25.06.15.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, some participants experienced improvements in central retinal thickness, tear production, diabetic control and albuminuria.

    In plain wordsIn people with diabetic macular edema, some, but not all, had better retinal thickness, tear production, diabetes control and urine protein after cibinetide.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    MixedIndividual improvements in CRT, tear production, diabetic control and albuminuria
    Study

    n = 9

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria.
    3 context sentences
    Summary · context
    Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria.
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  2. 02HumanNon-randomized trialSafety outcome

    In adults with diabetic macular edema, no serious adverse events or reactions were seen with 12 weeks of cibinetide.

    In plain wordsIn people with diabetic macular edema, no serious side effects were seen during 12 weeks of cibinetide.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeSerious adverse events and reactions
    Study

    n = 9

    Outcome group
    Adverse events · Whole body
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No serious adverse events/reactions
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In adults with diabetic macular edema, no anti-cibinetide antibodies were seen after 12 weeks of cibinetide.

    In plain wordsIn people with diabetic macular edema, no antibodies against cibinetide were found after 12 weeks of treatment.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeAnti-cibinetide antibodies
    Study

    n = 9

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    anti-cibinetide antibodies were seen.
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, 12 weeks of cibinetide gave no improvement in mean change in best corrected visual acuity from baseline.

    In plain wordsIn people with diabetic macular edema, 12 weeks of cibinetide did not improve best corrected vision compared with the start.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeChange in best corrected visual acuity (BCVA)
    Study

    n = 8

    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    BCVA mean change
    −2.9 NA
    baseline to week 12

    Source sentences

    Summary
    There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0)
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  5. 05HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, 12 weeks of cibinetide gave no improvement in mean change in central retinal thickness from baseline.

    In plain wordsIn people with diabetic macular edema, 12 weeks of cibinetide did not improve retinal thickness compared with the start.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeChange in central retinal thickness (CRT)
    Study

    n = 8

    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    CRT mean change
    10 microns
    baseline to week 12

    Source sentences

    Summary
    CRT (10 + 94.6 microns)
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, 12 weeks of cibinetide gave no improvement in mean change in central retinal sensitivity from baseline.

    In plain wordsIn people with diabetic macular edema, 12 weeks of cibinetide did not improve central retinal sensitivity compared with the start.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeChange in central retinal sensitivity
    Study

    n = 8

    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Central retinal sensitivity mean change
    −0.53 dB
    baseline to week 12

    Source sentences

    Summary
    central retinal sensitivity (-0.53 + 1.9 dB)
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, 12 weeks of cibinetide gave no improvement in mean change in tear production from baseline.

    In plain wordsIn people with diabetic macular edema, 12 weeks of cibinetide did not improve tear production compared with the start.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    No significant changeChange in tear production
    Study

    n = 8

    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Tear production mean change
    −0.13 mm
    baseline to week 12

    Source sentences

    Summary
    tear production (-0.13 + 7.7 mm)
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
  8. 08HumanNon-randomized trialEfficacy outcome

    In adults with diabetic macular edema, 12 weeks of cibinetide was followed by an improvement in the NEI VFQ-25 composite score from baseline.

    In plain wordsIn people with diabetic macular edema, patient-reported vision function scores improved after 12 weeks of cibinetide, compared with the start.

    Peptide
    Cibinetide (ARA-290)
    Outcome
    IncreaseChange in NEI VFQ-25 composite score
    Study

    n = 8

    Outcome group
    Vision and retina · Eye
    Studied dose
    4 mg/day · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    NEI VFQ-25 composite score mean change
    2.7 NA
    baseline to week 12

    Source sentences

    Summary
    there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:13 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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