UveitisPhase 4NCT02764697
Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
A Phase 4 study testing H.P. ACTHAR SUBCUTANEOUS GEL INJECTION in people with Uveitis and Anterior Uveitis, run by Tampa Bay Uveitis Center, LLC at 1 site in United States.
Trial summary
Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Anterior Uveitis, Intermediate Uveitis
- What is being tested?
- H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 20 Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject has the ability to understand and sign the informed consent document
- Subject is 18 years of age or older
- Subject can be male or female
- Subject has negative Purified Protein Derivative (Tuberculosis skin test) or quantiferon TB Gold Test (blood test for TB) testing done in 3 months
- Subject has active ocular inflammation in at least one eye
- Subject has visual acuity in at least one eye of 20/400 or better.
Show all 9Show fewer
- Subject has a history of glaucoma or has actively treated glaucoma
- Subject is willing and able to comply with the study procedures
- Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study
Who cannot join
- Subject has any ocular infection
- Subject has any systemic infection
- Participant has documented immunocompromised or immune-incompetent state
- Subject has any ocular co-morbidity than prevents assessment of intraocular inflammation
- Subject has had any intra-ocular surgery in previous 6 weeks
- Subject has any planned elective surgery ocular or systemic during study duration
Show all 10Show fewer
- Subject is pregnant or breast-feeding
- Subject had a recent vaccination with live or attenuated vaccines
- Subject has a sensitivity to Porcine derived proteins
- Subject has a medical history which is a contraindication to receiving H.P. Acthar
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa Bay Uveitis Center
St. Petersburg, Florida, 33709
About this study
Official title: Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids Cause Intolerable Side-Effects
Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
Read the detailed description
Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision.
H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol. Additionally H.P. Acthar gel is also reported to bind to melanocortin receptors. Melanocortin receptor activation has been shown to exert marked anti-inflammatory and immune-modulatory effects in animal studies, by modulating pro inflammatory cytokines, followed by induction of anti- inflammatory mediators and subsequent leukocyte migration. Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells. For this reason H.P. Acthar is an approved treatment for ocular inflammatory disease.
Ocular inflammatory disease is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
Subjects will be treated with H P Acthar subcutaneous gel, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses with the same cumulative units to be administered, using the approved route, with the option to do 4 additional doses if resolution is incomplete.
This will be a prospective open-label, non-randomized pilot study: 12 week treatment for active non-infectious uveitis, endpoint assessment and safety assessment; additional 12 week assessment for uveitis activity/quiescence and safety assessment.
- Conditions
- Uveitis, Anterior Uveitis, Intermediate Uveitis, Posterior Uveitis, Scleritis, Clinically Significant Macular Edema
- Being tested
- H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
- Keywords
- Glaucoma associated with uveitis
- Medical subject headings
- Uveitis, Uveitis, Anterior, Uveitis, Intermediate, Uveitis, Posterior, Scleritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. ACTHAR SUBCUTANEOUS GEL INJECTIONDrug
Also called Acthar
Subcutaneous injection twice weekly
| Study group | Role | What they receive |
|---|---|---|
| H.P. Acthar Subcutaneous Gel Injection | Other | For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. Receives: Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography
Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
Measured: 12 Weeks
Number of Participants With Clinically Significant Improvement of Macular Edema
Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start30 Jun 2016
- Primary completion7 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa Bay Uveitis Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Grace L Clarke, Principal investigator, Tampa Bay Uveitis Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764697
- Sponsor's protocol ID
- TBUC 10012015
- Status last verified
- Jun 2018
- First submitted
- 25 Apr 2016
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids Cause Intolerable Side-Effects
- ClinicalTrials.gov ID
- NCT02764697
- Acronym / sponsor ID
- TBUC 10012015
- Conditions
- Uveitis, Anterior Uveitis, Intermediate Uveitis, Posterior Uveitis, Scleritis, Clinically Significant Macular Edema
- Keywords
- Glaucoma associated with uveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tampa Bay Uveitis Center, LLCUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 2 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
Detailed description
Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision.
H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol. Additionally H.P. Acthar gel is also reported to bind to melanocortin receptors. Melanocortin receptor activation has been shown to exert marked anti-inflammatory and immune-modulatory effects in animal studies, by modulating pro inflammatory cytokines, followed by induction of anti- inflammatory mediators and subsequent leukocyte migration. Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells. For this reason H.P. Acthar is an approved treatment for ocular inflammatory disease.
Ocular inflammatory disease is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
Subjects will be treated with H P Acthar subcutaneous gel, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses with the same cumulative units to be administered, using the approved route, with the option to do 4 additional doses if resolution is incomplete.
This will be a prospective open-label, non-randomized pilot study: 12 week treatment for active non-infectious uveitis, endpoint assessment and safety assessment; additional 12 week assessment for uveitis activity/quiescence and safety assessment.
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 Subcutaneous Gel Injection | Other | Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTIONFor the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has the ability to understand and sign the informed consent document
- Subject is 18 years of age or older
- Subject can be male or female
- Subject has negative Purified Protein Derivative (Tuberculosis skin test) or quantiferon TB Gold Test (blood test for TB) testing done in 3 months
- Subject has active ocular inflammation in at least one eye
Key exclusion criteria (10 listed)
- Subject has any ocular infection
- Subject has any systemic infection
- Participant has documented immunocompromised or immune-incompetent state
- Subject has any ocular co-morbidity than prevents assessment of intraocular inflammation
- Subject has had any intra-ocular surgery in previous 6 weeks
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 SUBCUTANEOUS GEL INJECTIONAlso: ActharSubcutaneous injection twice weekly | Drug | H.P. Acthar Subcutaneous Gel Injection |
Primary outcome
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography
Time frame: 12 Weeks
Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
Number of Participants With Clinically Significant Improvement of Macular Edema
Time frame: 12 weeks
Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Grace L Clarke principal investigator
Tampa Bay Uveitis Center, LLC
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 SUBCUTANEOUS GEL INJECTION in people with Uveitis and Anterior Uveitis, run by Tampa Bay Uveitis Center, LLC 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography (time frame: 12 Weeks). The study lists 2 primary outcomes in all. 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 2 Jul 2018.