An interventional study of Repository Corticotropin Injection and Repository Corticotropin Injection -Treatment Extension in Ocular Sarcoidosis, Panuveitis and Anterior Uveitis, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)
The initial treatment of ocular sarcoidosis usually relies on a combination of topical glucocorticoids and oral glucocorticoids, both of which are associated with significant ocular and systemic toxicities. Steroid-sparing therapies are limited by variable and unpredictable efficacy, prolonged time until clinical response, medication intolerance, and difficulties obtaining payor approval. As a result, it is not uncommon that treating physicians must choose between excessive glucocorticoid toxicity versus poor control of ocular inflammation. Ongoing ocular inflammation, in turn, leads to eventual visual loss and occasionally blindness.
There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in sarcoidosis uveitis. Adrenocorticotropic hormone, through activation of melanocortin receptors on leukocytes, can dampen immune responses through non-glucocorticoid dependent mechanisms. The proposed study will aim to define whether there is effectiveness for ACTHAR gel in these patients, delineate an effect dosing regimen, and provide information about the safety of this approach for moderate to severe ocular sarcoidosis.
ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was initially approved in 1952 by the FDA. It has since been approved for 19 indications including respiratory sarcoidosis, multiple sclerosis, and infantile spasms.
56 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 45 interventional studies indexed under Uveitis, Anterior.
Browse Uveitis, Anterior studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Compared within Uveitis, Anterior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Panuveitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.
Drug: Repository Corticotropin Injection · Drug: Repository Corticotropin Injection -Treatment Extension
Treatment with ACTHAR Gel for 24 weeks * Initial treatment with 80 units daily for ten days (induction phase) * Maintenance treatment with 80 units twice weekly (maintenance phase)
Also known as: H.P. Acthar Gel, ACTH Gel, ACTH
24 open label extension permitted in subjects who respond to treatment
Also known as: H.P. Acthar Gel, ACTH Gel, ACTH
Percentage of Patients With Clinically Significant Improvement in Visual Acuity
The primary outcome was percentage of patients meeting at least one of the following variables 1) improved visual acuity, 2) resolution of intraocular inflammation, 3) ability to taper ocular or oral steroids by at least 50% or 4) reduction of cystoid macular edema, with no worsening of any single one and no need for additional sarcoidosis therapies at 24 weeks .
Time frame: Measured at 24 weeks
Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation
Time frame: Measured at 24 weeks
Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50%
Time frame: Measured at 24 weeks
Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema
Time frame: Measured at 24 weeks
| Milestone | H.P. Achtar Gel 80 U |
|---|---|
| Started | 9 |
| Completed | 4 |
| Not completed | 5 |
| Withdrew: Physician decision | 4 |
| Withdrew: Adverse event | 1 |
The primary outcome was percentage of patients meeting at least one of the following variables 1) improved visual acuity, 2) resolution of intraocular inflammation, 3) ability to taper ocular or oral steroids by at least 50% or 4) reduction of cystoid macular edema, with no worsening of any single one and no need for additional sarcoidosis therapies at 24 weeks .
| Participants | H.P. Achtar Gel 80 U |
|---|---|
| Percentage of Patients With Clinically Significant Improvement in Visual Acuity | 3 |
| Participants | H.P. Achtar Gel 80 U |
|---|---|
| Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation | 2 |
| Participants | H.P. Achtar Gel 80 U |
|---|---|
| Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50% | 2 |
| Participants | H.P. Achtar Gel 80 U |
|---|---|
| Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema | 1 |
Collected over 24 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| H.P. Achtar Gel 80 U | 0/9 (0%) | 0/9 (0%) | 7/9 (77.8%) |
| Event | H.P. Achtar Gel 80 U |
|---|---|
| Fluid RetentionVascular disorders | 7/9 |
| InsomniaGeneral disorders | 4/9 |
| HypertensionVascular disorders | 4/9 |
| DepressionPsychiatric disorders | 3/9 |
| Impaired Blood SugarMetabolism and nutrition disorders | 3/9 |
| Age, Continuous(years) | H.P. Achtar Gel 80 U |
|---|---|
| Median | 51 (35 to 71) |
| Sex: Female, Male(Participants) | H.P. Achtar Gel 80 U |
|---|---|
| Female | 6 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | H.P. Achtar Gel 80 U |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Adrenocorticotropic Hormone