A Phase 4 interventional study of Dexamethasone pellet in Uveitis, Intermediate and Uveitis, Posterior, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in which immunosuppressive drug therapy is indicated.
Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not treated.
The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or posterior uveitis.
In this study investigators want to see if using the implant together with systemic immunosuppressive drug therapy can result in lower ocular side effect profile but is effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these treatments is important because the kinds of uveitis being studied usually need to be treated for many years. This information may help researchers understand uveitis better and may suggest ways of improving treatment.
Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug therapy with high-dose corticosteroid is planned may join.
Objectives: This is a single arm study evaluating whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate or posterior uveitis in which immunosuppressive drug therapy is indicated.
Background: Intermediate and posterior uveitis are thought to be severe intraocular inflammation that may lead to permanent visual loss. It is estimated that these forms of uveitis comprise the fifth or sixth leading cause of blindness and tend to affect working class age patients, thus causing loss of work hours and diminished productivity and quality of life. Because the posterior segment of the eye is not adequately treated by corticosteroid drops often systemic drug therapy is used including oral corticosteroids or prednisone. Prednisone can have a myriad of side effects in approximately one-quarter to one-third of cases treated in tertiary care centers such as ours, additional medications such as immunosuppressive drugs are required to control the disease and/or to allow for appropriate tapering of oral prednisone to subsequent levels that have a low side effect profile when delivered over a long period of time. Typically, chronic prednisone therapy in doses of 7.5 mg daily or less are thought to have a low enough side effect profile to be amenable to long-term therapy. However frequently immunosuppressive drugs are required to get the dosing to this level. There are occasions when patients are intolerant of any dose of oral corticosteroids or are intolerant of the higher doses of oral corticosteroids (30 - 60 mg daily) and therefore this treatment modality is avoided due to prednisone's attendant side effects. Although periocular and intravitreal corticosteroids injections may be performed, with these modalities the standard of care is to wait until the disease reactivates before instituting such therapy and therefore a chronic suppressive dose is not obtained. The fluocinolone acetonide implant (Retisert®, Bausch and Lomb, Tampa, FL) is FDA-approved for the treatment of intermediate and posterior uveitis and it is equally effective in controlling uveitis as high-dose oral corticosteroids but avoids the systemic side effects associated with the use of high doses of oral corticosteroids. However, this form of local therapy has high rates of ocular side effects, including ocular hypertension causing glaucoma and/or requiring glaucoma surgery and cataracts. Furthermore, every two and half to three years the implant is exhausted of corticosteroid and therefore repeat surgical insertion of another implant may be required. A useful potential therapy for the treatment of these patients would be a shorter-acting local corticosteroid that could be delivered in conjunction with systemic immunosuppressive drug therapy that would have a lower ocular side effect profile but still would be effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate or posterior uveitis. It is possible that the dexamethasone pellet could fill this unique role in the treatment of uveitis. Investigators propose this study to evaluate dexamethasone pellet for this specific use among patients with active intermediate and posterior uveitis.
56 studies on the registry are indexed under Uveitis, Intermediate; 2 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 42 interventional studies indexed under Uveitis, Intermediate.
Browse Uveitis, Intermediate studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Drug: Dexamethasone pellet
Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination. Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
Also known as: Ozurdex pellet
Number of Participants With Absence of Intraocular Inflammation at 6 Months
Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
Time frame: at 6-month visit
Number of Participants With Absence of Intraocular Inflammation at 12 Months
Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
Time frame: 12-month clinical visit
Mean Intraocular Pressure (IOP)
Mean IOP (mmHg) was calculated at each visit
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months visit
Number of Eyes With a Need for Cataract Surgery
Number of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months visit
| Milestone | Dexamethasone Pellet |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
| Participants | Dexamethasone Pellet |
|---|---|
| Number of Participants With Absence of Intraocular Inflammation at 6 Months | 12 |
Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
| Participants | Dexamethasone Pellet |
|---|---|
| Number of Participants With Absence of Intraocular Inflammation at 12 Months | 13 |
Mean IOP (mmHg) was calculated at each visit
| millimeters of Mercury (mm Hg) | Dexamethasone Pellet |
|---|---|
| Baseline IOP | 13.2 ± 0.8 |
| Month 1 Visit | 18.2 ± 2.0 |
| Month 3 Visit | 14.6 ± 1.3 |
| Month 6 Visit | 14.1 ± 1.3 |
| Month 12 Visit | 13.5 ± 1.1 |
Number of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery.
| eyes | Dexamethasone Pellet |
|---|---|
| Baseline visit | 0 |
| Month 1 visit | 0 |
| Month 3 visit | 0 |
| Month 6 visit | 1 |
| Month12 visit | 3 |
Collected over All 20 patients were followed for 12 months after their first Ozurdex injection to look for adverse events. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Pellet | 0/20 (0%) | 0/20 (0%) | 13/20 (65%) |
| Event | Dexamethasone Pellet |
|---|---|
| Ocular hypertensionEye disorders | 7/20 |
| Cataract progressionEye disorders | 4/20 |
| Cataract surgeryEye disorders | 2/20 |
| Age, Continuous(years) | Dexamethasone Pellet |
|---|---|
| Median | 52 (27 to 82) |
| Sex: Female, Male(Participants) | Dexamethasone Pellet |
|---|---|
| Female | 17 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Dexamethasone Pellet |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Dexamethasone Pellet |
|---|---|
| United States | 20 |
| Type of uveitis(Participants) | Dexamethasone Pellet |
|---|---|
| Anterior and Intermediate | 7 |
| Intermediate | 4 |
| Posterior | 9 |
| Bilaterality of uveitis(Participants) | Dexamethasone Pellet |
|---|---|
| Unilateral | 0 |
| Bilateral | 20 |
| Activity of uveitis(Participants) | Dexamethasone Pellet |
|---|---|
| Active vitreous cell | 8 |
| Active vitreous haze | 4 |
| Active chorioretinal lesions | 2 |
| Active retinal vasculitis/leakage | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jan 2014, a primary completion of Jun 2018 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2019, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.