Sarcoid UveitisACTHNCT03473964
(ACTH) for the Treatment of Sarcoid Uveitis
An observational study of Sarcoid Uveitis, run by John Huang, MD at 1 site in United States.
Trial summary
Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoid Uveitis
- What is being tested?
- H.P. Acthar gel
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to Jan 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with sarcoid uveitis with disease activity, as determined by clinical exam, fluorescein angiography and optical coherence tomography.
Who may be able to join
- Presence of Sarcoid Uveitis as determined by
- clinical exam
- fluorescence angiography
- optical coherence tomography
Who cannot join
- Presence of long acting intraocular depots
- Women of childbearing age not using contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Retina Associates
Hamden, Connecticut, 06518
About this study
Official title: Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. The adverse effects of steroids may be avoided by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. These issues, will be explored in this research.
Read the detailed description
The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures:
The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks.
Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT).
Intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry
Quality of life assessment using National Eye Institute Visual Function Questionnaire (VFQ-25)
The Investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with Acthar® Gel over a period of 1 year.
- Conditions
- Sarcoid Uveitis
- Being tested
- H.P. Acthar gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. Acthar gelDrug
Also called adrenocorticotrophic hormone
H.P. Acthar gel:
Injection 40 mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Treatment | The study intervention is the observation of study subjects who have received H.P. Acthar® Gel (adrenocorticotrophic hormone), 40 units twice weekly injections in patients who have sarcoid uveitis and to assess it's effectiveness by measuring changes the degree of aqueous and vitreous inflammatory cells present, the degree of aqueous flare, and changes in visual acuity, macular thickness, intraocular pressure and quality of life measures assessed by using the National Eye Institute Visual Function Questionnaires (VFQ-25) Receives: Drug: H.P. Acthar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of aqueous and vitreous inflammatory cells-change is being assessed
Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN)
Measured: 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Secondary outcomes (5)
Degree of aqueous flare- change is being assessed
Degree of aqueous flare as graded by the criteria established by Standardization of Uveitis Nomenclature (SUN)
Measured: 0 weeks, 4 weeks 12 weeks and 24 weeks
Visual acuity- change is being assessed
Testing and evaluation of best corrected visual acuity using Luxvision trial frames and Precision Vision ETDRS charts R,1 and 2
Measured: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Central macular thickness- change is being assessed
Central macular thickness as measured by Spectralis Optical Coherence Tomography (OCT)
Measured: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Intraocular pressure
Intraocular pressure as measured by applanation tonometry
Measured: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Quality of life assessment- change is being assessed
Quality of life assessment using the National Eye Institute Visual Function Questionnaire (VFQ-25). The VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single item general health rating question. The scoring ranges in scores from 1-6, 1 being activity presents no difficulty and 6 being can no longer perform this activity due to vision. The VFQ-25 generates the following vision-targeted subscales : global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision(2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (I), and ocular pain (2).
Measured: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoid 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Huang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Huang, MD, New England Retina Associates
- Investigators
- John J Huang, MD, Principal investigator, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473964
- Sponsor's protocol ID
- 1169914
- Acronym
- ACTH
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
- ClinicalTrials.gov ID
- NCT03473964
- Acronym / sponsor ID
- ACTH / 1169914
- Conditions
- Sarcoid Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- John Huang, MDUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Mar 2018 (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.
Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. The adverse effects of steroids may be avoided by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. These issues, will be explored in this research.
Detailed description
The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures:
The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks.
Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT).
Intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry
Quality of life assessment using National Eye Institute Visual Function Questionnaire (VFQ-25)
The Investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with Acthar® Gel over a period of 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: H.P. Acthar gelThe study intervention is the observation of study subjects who have received H.P. Acthar® Gel (adrenocorticotrophic hormone), 40 units twice weekly injections in patients who have sarcoid uveitis and to assess it's effectiveness by measuring changes the degree of aqueous and vitreous inflammatory cells present, the degree of aqueous flare, and changes in visual acuity, macular thickness, intraocular pressure and quality of life measures assessed by using the National Eye Institute Visual Function Questionnaires (VFQ-25) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with sarcoid uveitis with disease activity, as determined by clinical exam, fluorescein angiography and optical coherence tomography.
Key inclusion criteria (4 listed)
- Presence of Sarcoid Uveitis as determined by
- clinical exam
- fluorescence angiography
- optical coherence tomography
Key exclusion criteria (2 listed)
- Presence of long acting intraocular depots
- Women of childbearing age not using contraceptives
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 gelAlso: adrenocorticotrophic hormoneH.P. Acthar gel: Injection 40 mg twice weekly | Drug | Treatment |
Primary outcome
Degree of aqueous and vitreous inflammatory cells-change is being assessed
Time frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN)
5 secondary outcomes
Degree of aqueous flare- change is being assessed
Time frame: 0 weeks, 4 weeks 12 weeks and 24 weeks
Visual acuity- change is being assessed
Time frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Central macular thickness- change is being assessed
Time frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Intraocular pressure
Time frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Quality of life assessment- change is being assessed
Time frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
John J Huang, MD principal investigator
New England Retina Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoid Uveitis, run by John Huang, MD 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 2 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 22 Mar 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.
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 John J Huang, MD (203-288-2020, jjqhuang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of aqueous and vitreous inflammatory cells-change is being assessed (time frame: 0 weeks, 4 weeks, 12 weeks and 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 22 Mar 2018.