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Study · Non-randomized trial · n = 35 · 2021

7 results

Repository Corticotropin Injection (Acthar® Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study.

Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J

Ophthalmology and therapy20 Oct 2021Cited by 11 (Europe PMC)

PMID34669183 (opens in a new tab)PMCIDPMC8589919 (opens in a new tab)DOI10.1007/s40123-021-00400-y (opens in a new tab)PepBankPUB-34669183
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, 50.0% had clinically important IDEEL symptom bother improvements at week 12 with Acthar Gel (95% CI 33.2%-66.8%).

    In plain wordsIn refractory severe noninfectious keratitis, half of patients had clinically important symptom bother improvements after Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseIDEEL symptom bother response
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Patients with clinically important IDEEL symptom bother improvement
    50%
    mITT population (N = 35), week 12
    95% confidence interval
    33.2 to 66.8%
    proportion with symptom bother improvement, week 12

    Source sentences

    Summary
    In the mITT population (N = 35), 50.0% (95% confidence interval, 33.2% to 66.8%) of patients experienced clinically important improvements in the symptom bother domain of the IDEEL Questionnaire at week 12 of RCI therapy.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  2. 02HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, all IDEEL domains improved at week 12 during Acthar Gel treatment.

    In plain wordsIn refractory severe noninfectious keratitis, all IDEEL questionnaire domains improved during Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseIDEEL domains
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    All domains of the IDEEL and the Ocular Discomfort and 4-Symptom Questionnaire showed improvements at week 12 of RCI treatment.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  3. 03HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, all Ocular Discomfort and 4-Symptom Questionnaire domains improved at week 12 during Acthar Gel treatment.

    In plain wordsIn refractory severe noninfectious keratitis, all eye discomfort questionnaire domains improved during Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseOcular Discomfort and 4-Symptom Questionnaire
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    All domains of the IDEEL and the Ocular Discomfort and 4-Symptom Questionnaire showed improvements at week 12 of RCI treatment.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  4. 04HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, eye dryness showed pronounced VAS improvement at week 12 during Acthar Gel treatment.

    In plain wordsIn refractory severe noninfectious keratitis, eye dryness improved during Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseEye dryness VAS
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most pronounced improvements in the VAS at week 12 were for eye dryness and eye discomfort.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  5. 05HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, eye discomfort showed pronounced VAS improvement at week 12 during Acthar Gel treatment.

    In plain wordsIn refractory severe noninfectious keratitis, eye discomfort improved during Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseEye discomfort VAS
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most pronounced improvements in the VAS at week 12 were for eye dryness and eye discomfort.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  6. 06HumanNon-randomized trialEfficacy outcome

    In refractory severe noninfectious keratitis, corneal staining, conjunctival staining, conjunctival redness, and tear production improved early and through week 12 during Acthar Gel treatment.

    In plain wordsIn refractory severe noninfectious keratitis, staining, redness, and tear production improved early and through week 12 during Acthar Gel treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    MixedOcular signs and tear production
    Study

    n = 35

    Outcome group
    Eye symptoms · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Corneal staining, conjunctival staining, conjunctival redness, and tear production showed early improvements that were sustained through week 12.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…
  7. 07HumanNon-randomized trialSafety outcome

    In refractory severe noninfectious keratitis, investigators identified no new safety signals for Acthar Gel.

    In plain wordsIn refractory severe noninfectious keratitis, investigators identified no new safety signals for Acthar Gel.

    Peptide
    ACTH (corticotropin)
    Outcome
    Direction not reportedNew safety signals
    Study

    n = 35

    Outcome group
    Adverse events · Eye
    Studied dose
    80 U twice weekly · subcutaneous · 12 weeks followed by a 4-week taperAs given in this study (human).

    Source sentences

    Summary
    No new safety signals for RCI were identified.
    1 context sentence
    Summary · context
    This phase 4, multicenter, open-label study assessed the efficacy and safety of RCI for refractory severe noninfectious keratitis.MethodsPatients were ≥ 18 years old with persistent severe keratitis despite treatment with topical immunosuppressants. Patients received 80 U of RCI subcutaneou…

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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