Uveitis, PosteriorPhase 4NCT03066869
Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
A Phase 4 study testing H.P. ACTHAR GEL in people with Uveitis, Posterior and Vasculitis Retinal, run by Ocular Immunology and Uveitis Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Posterior, Vasculitis Retinal
- What is being tested?
- H.P. ACTHAR GEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ocular Immunology & Uveitis Foundation
Waltham, Massachusetts, 02451
C. Stephen Foster, MD, 781-891-6377, sfoster@mersi.com
Stephen D. Anesi, MD, 781-891-6377, sanesi@mersi.com
About this study
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
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.
- Conditions
- Uveitis, Posterior, Vasculitis Retinal
- Being tested
- H.P. ACTHAR GEL
- Medical subject headings
- Uveitis, Posterior, Retinal Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. ACTHAR GELDrug
H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.
| Study group | Role | What they receive |
|---|---|---|
| H.P. ACTHAR GEL | Experimental | Not described Receives: Drug: H.P. ACTHAR GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 24 Weeks
Secondary outcomes (3)
Presence or absence of active retinal vasculitis at all other time points.
Measured: 1 Day to 24 Weeks
Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.
Measured: 1 Day to 24 Weeks
Percentage of patients requiring rescue therapy.
Measured: 1 Day to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start22 Mar 2017
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Immunology and Uveitis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066869
- Sponsor's protocol ID
- 120160924
- Status last verified
- Sep 2019
- First submitted
- 30 Dec 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03066869
- Acronym / sponsor ID
- 120160924
- Conditions
- Uveitis, Posterior, Vasculitis Retinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ocular Immunology and Uveitis FoundationUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.P. ACTHAR GEL | Experimental | Drug: H.P. ACTHAR GEL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.P. ACTHAR GELH.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases. | Drug | H.P. ACTHAR GEL |
Primary outcome
Percentage of responders to Acthar at the end of treatment.
Time frame: 24 Weeks
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".
3 secondary outcomes
Presence or absence of active retinal vasculitis at all other time points.
Time frame: 1 Day to 24 Weeks
Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.
Time frame: 1 Day to 24 Weeks
Percentage of patients requiring rescue therapy.
Time frame: 1 Day to 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing H.P. ACTHAR GEL in people with Uveitis, Posterior and Vasculitis Retinal, run by Ocular Immunology and Uveitis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C. Stephen Foster, MD (781-891-6377, sfoster@mersi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responders to Acthar at the end of treatment. (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.