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Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

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ClinicalTrials.gov Identifier: NCT03727776
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

This is a pilot study to measure levels of albumin and inflammatory cytokines [including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adrenocorticotropic hormone (ACTH) analog. The study will be conducted at the Wilmer Eye Institute, Johns Hopkins Hospital. A total of 10 patients will be enrolled. Treatment duration will be 8 weeks and study duration will be 12 weeks. There will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12).

Subjects will self-administer subcutaneous injections of 80 units of H.P. Acthar® starting on post-operative day 1 for twice a week until week 8. Aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. Aqueous levels of albumin and inflammatory cytokines (including TGF-β and IL-1β) will be measured at each time point.


Condition or disease Intervention/treatment Phase
Proliferative Vitreoretinopathy Drug: Adrenocorticotropic Hormone Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: H.P. Acthar ®
Subjects will self-administer subcutaneous injections of 80 units of adrenocorticotropic hormone analog starting on post-operative day 1 for twice a week until week 8.
Drug: Adrenocorticotropic Hormone
Adrenocorticotropic hormone (ACTH) is a melanocortin peptide hormone that is normally produced in the pituitary gland and acts as a major regulator of adrenal cortex function. It stimulates the adrenal cortex to produce and secrete glucocorticoids. ACTH is available for clinical usage as an injectable gel (H.P. Acthar®).
Other Names:
  • H.P. Acthar Gel
  • Repository Corticotropin Injection




Primary Outcome Measures :
  1. Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: Baseline, 1 day after surgery, 1 week after surgery, 8 weeks after surgery ]
    The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl

  2. Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: Baseline, 1 day after surgery, 1 week after surgery, 8 weeks after surgery ]
    The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl

  3. Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: Baseline, 1 day after surgery, 1 week after surgery, 8 weeks after surgery ]
    The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl


Secondary Outcome Measures :
  1. Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery ]
    Aqueous cell is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+, with 0 meaning no aqueous cell and 4+ meaning severe aqueous cell

  2. Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery ]
    Flare is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+ with 0 meaning no flare and 4+ means severe flare

  3. Change in best-corrected visual acuity as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) score in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® [ Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks after surgery ]
    The ETDRS score is a standardized score to assess visual acuity used in clinical research. The score ranges from 0 to 100, with higher scores corresponding to better visual acuity (a score of 100 corresponding to a Snellen visual acuity of 20/10).

  4. Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® who develop recurrent retinal detachment [ Time Frame: 12 weeks after surgery ]
    Recurrent retinal detachment is a common complication of PVR. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.

  5. Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® who develop macular edema [ Time Frame: 12 weeks after surgery ]
    Macular edema is a common complication of intraocular surgery. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Signed informed consent and authorization of use and disclosure of protected health information
  • Patients undergoing surgery for retinal detachment due to PVR

Exclusion Criteria:

  • Patients with a known diagnosis of diabetes mellitus (or those with HbA1C ≥ 6.5%)
  • Patients with hypertension (clinically diagnosed and on antihypertensive medication)
  • Patients with congestive heart failure
  • Patients with scleroderma
  • Patients with osteoporosis
  • Patients with active systemic fungal infection
  • Patients with active ocular herpes simplex
  • Patients with prior or active bleeding peptic ulcer
  • Pregnant patients or patients who wish to become pregnant during the course of the study (females of child-bearing age will be counselled to use contraception for the duration of the study)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727776


Contacts
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Contact: Gulnar Hafiz, MD, MPH 4105020768 ghafiz1@jhmi.edu

Locations
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United States, Maryland
Wilmer Eye Institute, Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gulnar Hafiz, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
Mallinckrodt
Investigators
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Principal Investigator: Peter A Campochiaro, MD Wilmer Eye Institute, Johns Hopkins School of Medicine

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03727776     History of Changes
Other Study ID Numbers: IRB00179012
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
Post-operative Intraocular Inflammation
Additional relevant MeSH terms:
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Vitreoretinopathy, Proliferative
Inflammation
Pathologic Processes
Retinal Diseases
Eye Diseases
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action