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

Primary Purpose

Uveitis, Posterior, Vasculitis Retinal

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
H.P. ACTHAR GEL
Sponsored by
Ocular Immunology and Uveitis Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis, Posterior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Ocular Immunology & Uveitis FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H.P. ACTHAR GEL

Arm Description

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Presence or absence of active retinal vasculitis at all other time points.
Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.
Percentage of patients requiring rescue therapy.

Full Information

First Posted
December 30, 2016
Last Updated
September 10, 2019
Sponsor
Ocular Immunology and Uveitis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03066869
Brief Title
Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
Official Title
Open-label, Single-center, Prospective Study on the Efficacy and Safety of Repository Corticotropin Injection (H.P. ACTHAR GEL) in the Treatment of Adults With Non-infectious Retinal Vasculitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Immunology and Uveitis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Posterior, Vasculitis Retinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
H.P. ACTHAR GEL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
H.P. ACTHAR GEL
Intervention Description
H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.
Primary Outcome Measure Information:
Title
Percentage of responders to Acthar at the end of treatment.
Description
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 Outcome Measure Information:
Title
Presence or absence of active retinal vasculitis at all other time points.
Time Frame
1 Day to 24 Weeks
Title
Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.
Time Frame
1 Day to 24 Weeks
Title
Percentage of patients requiring rescue therapy.
Time Frame
1 Day to 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C. Stephen Foster, MD
Phone
781-891-6377
Email
sfoster@mersi.com
Facility Information:
Facility Name
Ocular Immunology & Uveitis Foundation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Stephen Foster, MD
Phone
781-891-6377
Email
sfoster@mersi.com
First Name & Middle Initial & Last Name & Degree
Stephen D. Anesi, MD
Phone
781-891-6377
Email
sanesi@mersi.com
First Name & Middle Initial & Last Name & Degree
C. Stephen Foster, MD
First Name & Middle Initial & Last Name & Degree
Stephen D. Anesi, MD
First Name & Middle Initial & Last Name & Degree
Peter Chang, MD

12. IPD Sharing Statement

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

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