CClinicalTrials.gg
Status unknownNCT03066869Updated Sep 12, 2019

Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis

A Phase 4 interventional study of H.P. ACTHAR GEL in Uveitis, Posterior and Vasculitis Retinal, sponsored by Ocular Immunology and Uveitis Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Ocular Immunology and Uveitis Foundation · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.

02

Conditions studied

  • Uveitis, Posterior
  • Vasculitis Retinal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any adult patient with active retinal vasculitis (involving arteries or veins) as a manifestation of non-infectious ocular inflammatory disease; fundus must be viewable with wide-field FA in the study eye
  • If both eyes are involved, both are eligible for inclusion in the study
  • Patients already on non-steroidal immunosuppressive therapy may continue on this during the study, but the dose must not be increased or decreased within 6 weeks of initiating the trial
  • Willing and able to sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Patients under age 18
  • Patients who are pregnant (must be ruled out in women of child-bearing age)
  • Active infectious ocular or systemic disease
  • Patients with active infectious ocular or extraocular disease
  • Patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously
  • Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction
  • Patients with known hypersensitivity to Acthar
  • Patients on other non-steroidal systemic immunomodulatory medications with dose adjusted sooner than 6 weeks prior to study drug administration
  • Patients currently on or recently treated with (within 6 weeks) systemic corticosteroid
  • Patients with periocular or intraocular injections of medications administered to help control inflammation sooner than 6 weeks prior to study drug administration
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator, or contraindicated, including but not limited to, patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Administration of live or live attenuated vaccines is contraindicated in patients during the entire duration of the study and for one month prior
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    H.P. ACTHAR GEL

    Drug: H.P. ACTHAR GEL

Interventions

  • DrugH.P. ACTHAR GEL

    H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.

05

What researchers measure

Primary outcomes

  1. Percentage of responders to Acthar at the end of treatment.

    A responder will be defined by the binominal presence or absence of active retinal vasculitis as evaluated at Week 24. Active retinal vasculitis is defined as angiographic leakage from retinal arterioles, venules, or capillaries as determined by investigator, seen on wide-field angiography. Complete resolution or absence of active retinal vasculitis at Week 24 is considered success or "remission".

    Time frame: 24 Weeks

Secondary outcomes

  1. Presence or absence of active retinal vasculitis at all other time points.

    Time frame: 1 Day to 24 Weeks

  2. Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.

    Time frame: 1 Day to 24 Weeks

  3. Percentage of patients requiring rescue therapy.

    Time frame: 1 Day to 24 Weeks

06

Study locations

1 of 1 sites recruiting
  • Ocular Immunology & Uveitis Foundation
    Waltham, Massachusetts 02451, United States
    • C. Stephen Foster, MD · Contact · sfoster@mersi.com · 781-891-6377
    • Stephen D. Anesi, MD · Contact · sanesi@mersi.com · 781-891-6377
    • C. Stephen Foster, MD · Principal investigator
    • Stephen D. Anesi, MD · Sub investigator
    • Peter Chang, MD · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03066869
Lead sponsor
Ocular Immunology and Uveitis Foundation
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Mar 22, 2017
Primary completion
Feb 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Sep 12, 2019

Study contacts

C. Stephen Foster, MD
Contact
sfoster@mersi.com
781-891-6377

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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