UveitisPhase 1/2NCT01195948
Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
A Phase 1/2 study testing B27PD in people with Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Uveitis is a serious inflammatory condition in which the body's immune system attacks parts of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress the immune system, but these medicines sometimes do not work or may cause serious side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- B27PD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2014
- Phase
- Phase 1/2
- 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
- Participant must be 18 years of age or older.
- Participant must be able to understand the informed consent process and sign the informed consent form.
- Participant has been diagnosed with non-infectious unilateral or bilateral uveitis for at least three months. Participants who were diagnosed more than a year prior to enrollment must have had a recurrence in ocular inflammation within the past year.
- Participant must be receiving a current treatment with prednisone between 20 to 40 mg/day (or an equipotent dose of an alternative corticosteroid). Participants who are on a regimen of no more than one anti-metabolite inhibitor at the time of randomization (e.g., azathioprine, methotrexate, mycophenolate) in addition to the prednisone may be enrolled and are allowed to continue the anti-metabolite.
- The participant's uveitis must be controlled in eligible eyes, quiescent eyes [anterior chamber cells and vitreous haze Standardization of Uveitis Nomenclature (SUN) grade of 0].
- The participant's eligible eye(s) is able to be evaluated for activity of disease both biomicroscopically and ophthalmoscopically.
Show all 10Show fewer
- The participant's baseline intraocular pressure must be > 5 mmHg and ≤ to 30 mmHg in both eyes. Concurrent use of intraocular pressure-lowering medication and/or prior glaucoma surgery is acceptable.
- Participant has best-corrected distance visual acuity in the better seeing eye of 20/200 or better [≥ 34 Early Treatment Diabetic Retinopathy Study (ETDRS) letters].
- Female participants of childbearing potential must not be pregnant or lactating and must be willing to undergo serum pregnancy tests throughout the study.
- Women of childbearing potential must agree to use reliable methods of contraception while receiving the study medication and for 6 weeks following the last administration. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or partner with vasectomy).
Who cannot join
- Participant has a non-iatrogenic immunodeficiency state [e.g., Human Immunodeficiency Virus (HIV) infection or congenital immunodeficiency].
- Participant had intraocular surgery or intraocular injection within three months prior to randomization.
- Participant is expected to have an elective ocular surgery or intraocular injection during the study period.
- Participant is using systemic corticosteroid therapy for a non-ocular disease or non-ocular organ involvement.
- Participant has a history or diagnosis of Behcet's disease.
- Participant has a clinically suspected and/or confirmed central nervous system or ocular lymphoma.
Show all 17Show fewer
- Participant has an active systemic infectious disease or malignancy that requires treatment.
- Participant has a known chronic disease or condition of the gastrointestinal system that may interfere wih the absorption of the investigational product as determined by the investigator (e.g., active hepatitis, chronic diarrhea, inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, diverticulosis or diverticulitis).
- Participant has two or more food allergies.
- Participant has an implant containing anti-inflammatory, immunosuppressive or antiviral drugs, unless a period 50% longer than the anticipated duration of effect of the implant has elapsed.
- Participant received periocular corticosteroid injections within 4 months prior to randomization or is expected to need periocular corticosteroid injections during the study duration.
- Participant received treatment with infliximab, etanercept, adalimumab, interferon, cyclosporine, tacrolimus, sirolimus, within two weeks prior to randomization.
- Participant received cytotoxic therapy (e.g., cyclophosphamide) within six months prior to randomization.
- Participants for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study.
- Participant who is unlikely to comply with the study protocol or who is likely to be moving or lost to follow-up.
- Participant who is currently enrolled or has been participating in any other investigative therapeutic clinical trial during the three months prior to randomization.
- Participant has a known need for a colonoscopy or surgery of the gastrointestinal tract during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Peptide B27PD (Optiquel®) as Corticosteroid-sparing Therapy for Chronic Non-infectious Uveitis (BOOTS)
Background:
Uveitis is a serious inflammatory condition in which the body's immune system attacks parts of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress the immune system, but these medicines sometimes do not work or may cause serious side effects. Researchers are interested in developing new treatments for uveitis that are more effective and have fewer side effects.
Read more
Optiquel® is an experimental medication being tested for its effectiveness against uveitis. It contains B27PD, a small protein fragment, which is similar to proteins in the parts of the eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce oral tolerance, in which the immune system is taught to recognize and not attack normal parts of the human body.
Objectives:
To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.
Eligibility:
Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking daily prednisone or an equivalent medication.
Design:
Participants will be screened with a physical examination, medical history, blood and urine tests, and an eye exam.
This study will last a maximum of 52 weeks. During the first 12 weeks of the study, participants will have a study visit every 2 weeks. For the remainder of the study, participants will have a study visit every 4 weeks.
Participants will have frequent blood and urine tests, and will also have eye examinations and special procedures (fluorescein angiography and indocyanine green angiography) to evaluate the effectiveness of the treatment.
Participants will be randomly assigned into one of three groups and will receive either one of two different doses of B27PD or a placebo. During the study, participants will also have their dose of prednisone or other steroid medication reduced.
Participants will take one capsule three times per week on Monday, Wednesday, and Friday, for a total of 24 weeks. Participants may take the capsule with water, but should not consume any other drinks or any kind of food until at least 30 minutes have passed to prevent stomach upset. The capsules should be stored in the refrigerator.
Read the detailed description
Objective: The objective of this study is to evaluate the safety and efficacy of the peptide B27PD (Optiquel®) as a corticosteroid-sparing agent for chronic non-infectious uveitis in participants receiving oral corticosteroid therapy alone or combined with an immunosuppressive agent in a proof-of-concept clinical trial.
Study Population: Patients with non-infectious uveitis requiring at least 20 mg but no more than 40 mg of oral prednisone, or equipotent dose of alternative corticosteroid medication to maintain a quiescent eye, will be eligible.
Design: In this single center, Phase I/II, double-masked, randomized, placebo-controlled, parallel group treatment study, the safety and efficacy of the peptide B27PD will be investigated in 60 participants with non-infectious uveitis. Initially, 60 participants were to be enrolled; however, due to lack of efficacy, only 31 participants were enrolled. Eligible participants will be randomized to one of three treatment groups: 1 mg B27PD, 4 mg B27PD or placebo, to be taken three times per week for 24 weeks. All remaining participants will be followed through a common termination date. The common termination date will be established once the last enrolled participant reaches his/her Week 28 visit (four weeks following his/her last investigational treatment).The time to recurrence of uveitis in either eye occurring in the 52 weeks following the initial dosing will be evaluated in each treatment group. Recurrence will be defined as an increase in anterior chamber cells and/or vitreous haze of at least 2 steps [using the Standardization of Uveitis Nomenclature (SUN) grading system]. Ophthalmic examinations to assess uveitis will include visual acuity, intraocular pressure (IOP), slit lamp biomicroscopy, ophthalmoscopy, optical coherence tomography (OCT) and fluorescein angiography.
Outcome Measures: The primary outcome variable is the time to recurrence of uveitis activity in participants of each treatment group, during or after tapering of oral prednisone to a dose of 7.5 mg/day, or equipotent dose of alternative corticosteroid medication. Secondary efficacy outcome variables include the proportion of participants determined to be a Treatment Failure, defined as recurrence (or flare) of uveitis (at least a 2-step increase using the SUN grading system) or a drop in visual acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 24 and 52 weeks. Other secondary efficacy outcomes include the reduction in exposure to corticosteroid as measured by the area under the dose-time curve, and changes in best-corrected visual acuity (BCVA), fluorescein angiography, fundus autofluorescence and high-speed indocyanine green angiography (HS-ICG). Ocular safety measurements include intraocular pressure (IOP) and optical coherence tomography (OCT) for confirmation of suspected macular edema. Systemic safety variables include adverse events, clinical blood chemistry and hematology, urinalysis, vital signs, weight and medical evaluation at baseline and at the end of the study.
- Conditions
- Uveitis
- Being tested
- B27PD, Placebo
- Keywords
- Uveitis, Oral Tolerance
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B27PDDrug
Also called Optiquel®
PlaceboDrug
Capsule with no active ingredients to mimic B27PD
| Study group | Role | What they receive |
|---|---|---|
| B27PD 1 mg | Experimental | Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. Receives: Drug: B27PD |
| B27PD 4 mg | Experimental | Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. Receives: Drug: B27PD |
| Placebo | Placebo comparator | Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.
Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system.
The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation.
Measured: Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks
Secondary outcomes (8)
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system
Measured: Week 24
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system
Measured: Week 52
Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Measured: Baseline and Week 24
Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Measured: Baseline and Week 24
Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline
Measured: Week 24
Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline
Measured: Week 24
Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.
This outcome was not analyzed as no data was collected at Week 24.
Measured: Week 24
Changes in High-speed Indocyanine Green Angiography (HS-ICG)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionFeb 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Robert B Nussenblatt, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195948
- Sponsor's protocol ID
- 100191
- Other IDs
- 10-EI-0191
- Status last verified
- Dec 2014
- First submitted
- 3 Sep 2010
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman M, Fletcher MJ, Chasan-Taber S, Finger E, Morales A, Le CH, Trentham DE. Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 1998 Feb;41(2):290-7. doi: 10.1002/1529-0131(199802)41:23.0.CO;2-R.
PubMed 9485087Dandona L, Dandona R, John RK, McCarty CA, Rao GN. Population based assessment of uveitis in an urban population in southern India. Br J Ophthalmol. 2000 Jul;84(7):706-9. doi: 10.1136/bjo.84.7.706.
PubMed 10873978Levy RA, de Andrade FA, Foeldvari I. Cutting-edge issues in autoimmune uveitis. Clin Rev Allergy Immunol. 2011 Oct;41(2):214-23. doi: 10.1007/s12016-011-8267-x.
PubMed 21913066
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide B27PD (Optiquel®) as Corticosteroid-sparing Therapy for Chronic Non-infectious Uveitis (BOOTS)
- ClinicalTrials.gov ID
- NCT01195948
- Acronym / sponsor ID
- 100191
- Conditions
- Uveitis
- Keywords
- Uveitis, Oral Tolerance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 5 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Uveitis is a serious inflammatory condition in which the body's immune system attacks parts of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress the immune system, but these medicines sometimes do not work or may cause serious side effects. Researchers are interested in developing new treatments for uveitis that are more effective and have fewer side effects.
Optiquel® is an experimental medication being tested for its effectiveness against uveitis. It contains B27PD, a small protein fragment, which is similar to proteins in the parts of the eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce oral tolerance, in which the immune system is taught to recognize and not attack normal parts of the human body.
Objectives:
To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.
Eligibility:
Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking daily prednisone or an equivalent medication.
Design:
Participants will be screened with a physical examination, medical history, blood and urine tests, and an eye exam.
This study will last a maximum of 52 weeks. During the first 12 weeks of the study, participants will have a study visit every 2 weeks. For the remainder of the study, participants will have a study visit every 4 weeks.
Participants will have frequent blood and urine tests, and will also have eye examinations and special procedures (fluorescein angiography and indocyanine green angiography) to evaluate the effectiveness of the treatment.
Participants will be randomly assigned into one of three groups and will receive either one of two different doses of B27PD or a placebo. During the study, participants will also have their dose of prednisone or other steroid medication reduced.
Participants will take one capsule three times per week on Monday, Wednesday, and Friday, for a total of 24 weeks. Participants may take the capsule with water, but should not consume any other drinks or any kind of food until at least 30 minutes have passed to prevent stomach upset. The capsules should be stored in the refrigerator.
Detailed description
Objective: The objective of this study is to evaluate the safety and efficacy of the peptide B27PD (Optiquel®) as a corticosteroid-sparing agent for chronic non-infectious uveitis in participants receiving oral corticosteroid therapy alone or combined with an immunosuppressive agent in a proof-of-concept clinical trial.
Study Population: Patients with non-infectious uveitis requiring at least 20 mg but no more than 40 mg of oral prednisone, or equipotent dose of alternative corticosteroid medication to maintain a quiescent eye, will be eligible.
Design: In this single center, Phase I/II, double-masked, randomized, placebo-controlled, parallel group treatment study, the safety and efficacy of the peptide B27PD will be investigated in 60 participants with non-infectious uveitis. Initially, 60 participants were to be enrolled; however, due to lack of efficacy, only 31 participants were enrolled. Eligible participants will be randomized to one of three treatment groups: 1 mg B27PD, 4 mg B27PD or placebo, to be taken three times per week for 24 weeks. All remaining participants will be followed through a common termination date. The common termination date will be established once the last enrolled participant reaches his/her Week 28 visit (four weeks following his/her last investigational treatment).The time to recurrence of uveitis in either eye occurring in the 52 weeks following the initial dosing will be evaluated in each treatment group. Recurrence will be defined as an increase in anterior chamber cells and/or vitreous haze of at least 2 steps [using the Standardization of Uveitis Nomenclature (SUN) grading system]. Ophthalmic examinations to assess uveitis will include visual acuity, intraocular pressure (IOP), slit lamp biomicroscopy, ophthalmoscopy, optical coherence tomography (OCT) and fluorescein angiography.
Outcome Measures: The primary outcome variable is the time to recurrence of uveitis activity in participants of each treatment group, during or after tapering of oral prednisone to a dose of 7.5 mg/day, or equipotent dose of alternative corticosteroid medication. Secondary efficacy outcome variables include the proportion of participants determined to be a Treatment Failure, defined as recurrence (or flare) of uveitis (at least a 2-step increase using the SUN grading system) or a drop in visual acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 24 and 52 weeks. Other secondary efficacy outcomes include the reduction in exposure to corticosteroid as measured by the area under the dose-time curve, and changes in best-corrected visual acuity (BCVA), fluorescein angiography, fundus autofluorescence and high-speed indocyanine green angiography (HS-ICG). Ocular safety measurements include intraocular pressure (IOP) and optical coherence tomography (OCT) for confirmation of suspected macular edema. Systemic safety variables include adverse events, clinical blood chemistry and hematology, urinalysis, vital signs, weight and medical evaluation at baseline and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B27PD 1 mg | Experimental | Drug: B27PDParticipants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. |
| B27PD 4 mg | Experimental | Drug: B27PDParticipants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must be 18 years of age or older.
- Participant must be able to understand the informed consent process and sign the informed consent form.
- Participant has been diagnosed with non-infectious unilateral or bilateral uveitis for at least three months. Participants who were diagnosed more than a year prior to enrollment must have had a recurrence in ocular inflammation within the past year.
- Participant must be receiving a current treatment with prednisone between 20 to 40 mg/day (or an equipotent dose of an alternative corticosteroid). Participants who are on a regimen of no more than one anti-metabolite inhibitor at the time of randomization (e.g., azathioprine, methotrexate, mycophenolate) in addition to the prednisone may be enrolled and are allowed to continue the anti-metabolite.
- The participant's uveitis must be controlled in eligible eyes, quiescent eyes [anterior chamber cells and vitreous haze Standardization of Uveitis Nomenclature (SUN) grade of 0].
Key exclusion criteria (17 listed)
- Participant has a non-iatrogenic immunodeficiency state [e.g., Human Immunodeficiency Virus (HIV) infection or congenital immunodeficiency].
- Participant had intraocular surgery or intraocular injection within three months prior to randomization.
- Participant is expected to have an elective ocular surgery or intraocular injection during the study period.
- Participant is using systemic corticosteroid therapy for a non-ocular disease or non-ocular organ involvement.
- Participant has a history or diagnosis of Behcet's disease.
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 |
|---|---|---|
| B27PDAlso: Optiquel® | Drug | B27PD 1 mg, B27PD 4 mg |
| PlaceboCapsule with no active ingredients to mimic B27PD | Drug | Placebo |
Primary outcome
The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.
Time frame: Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks
Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system. The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation.
8 secondary outcomes
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
Time frame: Week 24
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
Time frame: Week 52
Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline
Time frame: Baseline and Week 24
Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline
Time frame: Baseline and Week 24
Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline
Time frame: Week 24
Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline
Time frame: Week 24
Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.
Time frame: Week 24
Changes in High-speed Indocyanine Green Angiography (HS-ICG)
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9485087Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman M, Fletcher MJ, Chasan-Taber S, Finger E, Morales A, Le CH, Trentham DE. Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 1998 Feb;41(2):290-7. doi: 10.1002/1529-0131(199802)41:23.0.CO;2-R.
- Background: PubMed 10873978Dandona L, Dandona R, John RK, McCarty CA, Rao GN. Population based assessment of uveitis in an urban population in southern India. Br J Ophthalmol. 2000 Jul;84(7):706-9. doi: 10.1136/bjo.84.7.706.
- Derived from this study: PubMed 21913066Levy RA, de Andrade FA, Foeldvari I. Cutting-edge issues in autoimmune uveitis. Clin Rev Allergy Immunol. 2011 Oct;41(2):214-23. doi: 10.1007/s12016-011-8267-x.
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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.
Robert B Nussenblatt, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing B27PD in people with Uveitis, run by National Eye Institute (NEI) 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 10 inclusion and 17 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 11 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Dec 2014). 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?
The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication. (time frame: Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195948, which also lists 3 linked publications.
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 11 Sep 2018.