UveitisPhase 1NCT00943982
The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
A Phase 1 study testing Interferon Gamma 1-b 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 that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to further vision loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Interferon Gamma 1-b
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2009to 24 Jun 2010
- Phase
- Phase 1
- 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 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 understand and sign the protocol's informed consent document.
- Participant has a diagnosis of intermediate, panuveitis or posterior uveitis at least three months prior to study enrollment and has associated CME secondary to uveitis in at least one eye (the study eye).
- Participant has a central macular thickness greater than or equal to 250 microns in the study eye.
- Participant is willing to comply with the study procedures and is expected to be able to return for all study visits.
- Participant has visual acuity of 20/200 or better in the study eye.
- Female participants of childbearing potential must not be pregnant or breast-feeding.
- Both female participants of childbearing potential and male participants able to father a child must agree to practice an adequate contraception during the study and for six weeks following the administration of study medication. 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 vasectomy).
Who cannot join
- Participant is expected to be unable to tolerate the ocular instillation.
- Participant is unable to undergo OCT testing.
- Participant had herpes keratitis in the past.
- Participant is diagnosed with multiple sclerosis.
- Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections that in the principal investigator's best medical judgment would preclude participation.
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
Background:
- Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to further vision loss. This condition is usually treated by medicines that target the immune system, but these medicines sometimes do not work or may cause side effects.
- Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is given as an intramuscular injection; however, this study will use the drug as an eye drop. This study represents the first time that interferon gamma-1b is given as an eye drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing the swelling in the back of the eye.
Read more
Objectives:
- To investigate the safety and effectiveness of treating uveitis-associated macular edema with interferon gamma-1b.
Eligibility:
- Individuals 18 years of age and older who have been diagnosed with macular edema associated with uveitis (in one or both eyes) for at least 3 months.
Design:
- Participants will have three planned clinic visits during this study over the course of 2 weeks.
- All participants will have a medical history and eye examination.
- When receiving the drops, participants will have optical coherence tomography (a detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving the drops; and 30, 60, and 120 minutes after receiving the drops.
- After receiving the drops, participants will have another eye examination, blood drawn for samples, and further scans.
- Participants will be asked to return to the NIH Clinical Center 1 week after receiving the drops for an evaluation....
Read the detailed description
Objective: Information gathered from our laboratories suggests that cystoid macular edema (CME) is caused by the disequilibrium of the Jak/Stat and mTor signal transduction pathways in the retinal pigment epithelium (RPE). We wish to investigate whether stimulating the Jak/Stat pathway with topically applied interferon gamma-1b can be a therapeutic intervention for the treatment of CME secondary to uveitis. The objective of this study is to investigate the safety and tolerability of ocular instillations(s) of interferon gamma-1b as an effective treatment for CME secondary to uveitis.
Study Population: Five participants with CME secondary to intermediate, panuveitis or posterior uveitis will receive a topical ocular instillation(s) of interferon gamma-1b.
Design: This Phase I, non-randomized, prospective, uncontrolled, dose-escalation, single-center study will involve a one-time instillation or series of instillations of interferon gamma-1b on the cornea and measure the potential response with optical coherence tomography (OCT) . Treatment success is defined as a 25% decrease in excess central macular thickening at any timepoint post-instillation as compared to baseline. The first two participants will receive one instillation (each instillation contains 10 microg in 0.05 mL solution), the next two participants will receive two instillations and the final participant will receive three instillations. OCT will be obtained at -60 minutes, -30 minutes and just before the instillation(s). Repeat OCTs will be taken at +30 minutes, +60 minutes and +120 minutes and again at the end of the day. All participants will return for a one-week safety visit.
Outcome Measures: The primary outcome is the change in excess central macular thickening as measured by OCT in response to interferon gamma-1b as compared with baseline. Secondary efficacy outcomes include changes in macular volume as measured by OCT, visual acuity, intraocular pressure, and intraocular inflammation as graded upon slit lamp examination. Secondary safety outcomes include ocular surface irritation assessed by fluorescein staining of the cornea and conjunctiva to assess toxicity changes in subjective ocular pain assessments as compared to baseline, number and severity of systemic and ocular toxicities and adverse events and the proportion of participants with a visual loss of greater than or equal to 15 ETDRS letters.
- Conditions
- Uveitis
- Being tested
- Interferon Gamma 1-b
- Keywords
- Cystoid Macular Edema, Intermediate Uveitis, Uveitis, OCT, Interferon-Gamma (IFN-Gamma)
- Medical subject headings
- Uveitis, Macular Edema, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Gamma 1-bDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in central macular thickness as measured by OCT as compared with baseline.
Secondary outcomes (1)
Secondary outcomes include: changes in macular volume as measured by OCT, changes in visual acuity, changes in intraocular pressure and changes in intraocular inflammation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study start17 Jul 2009
- Primary completion24 Jun 2010
- Study completion24 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943982
- Sponsor's protocol ID
- 090191
- Other IDs
- 09-EI-0191
- Status last verified
- 24 Jun 2010
- First submitted
- 21 Jul 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Andrews HE, Nichols PP, Bates D, Turnbull DM. Mitochondrial dysfunction plays a key role in progressive axonal loss in Multiple Sclerosis. Med Hypotheses. 2005;64(4):669-77. doi: 10.1016/j.mehy.2004.09.001.
PubMed 15694681Artuch R, Aracil A, Mas A, Colome C, Rissech M, Monros E, Pineda M. Friedreich's ataxia: idebenone treatment in early stage patients. Neuropediatrics. 2002 Aug;33(4):190-3. doi: 10.1055/s-2002-34494.
PubMed 12368988Artuch R, Aracil A, Mas A, Monros E, Vilaseca MA, Pineda M. Cerebrospinal fluid concentrations of idebenone in Friedreich ataxia patients. Neuropediatrics. 2004 Apr;35(2):95-8. doi: 10.1055/s-2004-815830.
PubMed 15127307
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
- ClinicalTrials.gov ID
- NCT00943982
- Acronym / sponsor ID
- 090191
- Conditions
- Uveitis
- Keywords
- Cystoid Macular Edema, Intermediate Uveitis, Uveitis, OCT, Interferon-Gamma (IFN-Gamma)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 17 Jul 2009
- Primary completion
- 24 Jun 2010 (actual)
- Study completion
- 24 Jun 2010 (actual)
- First posted
- 22 Jul 2009 (estimated)
- 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.
Background:
- Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to further vision loss. This condition is usually treated by medicines that target the immune system, but these medicines sometimes do not work or may cause side effects.
- Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is given as an intramuscular injection; however, this study will use the drug as an eye drop. This study represents the first time that interferon gamma-1b is given as an eye drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing the swelling in the back of the eye.
Objectives:
- To investigate the safety and effectiveness of treating uveitis-associated macular edema with interferon gamma-1b.
Eligibility:
- Individuals 18 years of age and older who have been diagnosed with macular edema associated with uveitis (in one or both eyes) for at least 3 months.
Design:
- Participants will have three planned clinic visits during this study over the course of 2 weeks.
- All participants will have a medical history and eye examination.
- When receiving the drops, participants will have optical coherence tomography (a detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving the drops; and 30, 60, and 120 minutes after receiving the drops.
- After receiving the drops, participants will have another eye examination, blood drawn for samples, and further scans.
- Participants will be asked to return to the NIH Clinical Center 1 week after receiving the drops for an evaluation....
Detailed description
Objective: Information gathered from our laboratories suggests that cystoid macular edema (CME) is caused by the disequilibrium of the Jak/Stat and mTor signal transduction pathways in the retinal pigment epithelium (RPE). We wish to investigate whether stimulating the Jak/Stat pathway with topically applied interferon gamma-1b can be a therapeutic intervention for the treatment of CME secondary to uveitis. The objective of this study is to investigate the safety and tolerability of ocular instillations(s) of interferon gamma-1b as an effective treatment for CME secondary to uveitis.
Study Population: Five participants with CME secondary to intermediate, panuveitis or posterior uveitis will receive a topical ocular instillation(s) of interferon gamma-1b.
Design: This Phase I, non-randomized, prospective, uncontrolled, dose-escalation, single-center study will involve a one-time instillation or series of instillations of interferon gamma-1b on the cornea and measure the potential response with optical coherence tomography (OCT) . Treatment success is defined as a 25% decrease in excess central macular thickening at any timepoint post-instillation as compared to baseline. The first two participants will receive one instillation (each instillation contains 10 microg in 0.05 mL solution), the next two participants will receive two instillations and the final participant will receive three instillations. OCT will be obtained at -60 minutes, -30 minutes and just before the instillation(s). Repeat OCTs will be taken at +30 minutes, +60 minutes and +120 minutes and again at the end of the day. All participants will return for a one-week safety visit.
Outcome Measures: The primary outcome is the change in excess central macular thickening as measured by OCT in response to interferon gamma-1b as compared with baseline. Secondary efficacy outcomes include changes in macular volume as measured by OCT, visual acuity, intraocular pressure, and intraocular inflammation as graded upon slit lamp examination. Secondary safety outcomes include ocular surface irritation assessed by fluorescein staining of the cornea and conjunctiva to assess toxicity changes in subjective ocular pain assessments as compared to baseline, number and severity of systemic and ocular toxicities and adverse events and the proportion of participants with a visual loss of greater than or equal to 15 ETDRS letters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (5 listed)
- Participant is expected to be unable to tolerate the ocular instillation.
- Participant is unable to undergo OCT testing.
- Participant had herpes keratitis in the past.
- Participant is diagnosed with multiple sclerosis.
- Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections that in the principal investigator's best medical judgment would preclude participation.
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 |
|---|---|---|
| Interferon Gamma 1-b | Drug | – |
Primary outcome
The primary outcome is the change in central macular thickness as measured by OCT as compared with baseline.
1 secondary outcome
Secondary outcomes include: changes in macular volume as measured by OCT, changes in visual acuity, changes in intraocular pressure and changes in intraocular inflammation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15694681Andrews HE, Nichols PP, Bates D, Turnbull DM. Mitochondrial dysfunction plays a key role in progressive axonal loss in Multiple Sclerosis. Med Hypotheses. 2005;64(4):669-77. doi: 10.1016/j.mehy.2004.09.001.
- Background: PubMed 12368988Artuch R, Aracil A, Mas A, Colome C, Rissech M, Monros E, Pineda M. Friedreich's ataxia: idebenone treatment in early stage patients. Neuropediatrics. 2002 Aug;33(4):190-3. doi: 10.1055/s-2002-34494.
- Background: PubMed 15127307Artuch R, Aracil A, Mas A, Monros E, Vilaseca MA, Pineda M. Cerebrospinal fluid concentrations of idebenone in Friedreich ataxia patients. Neuropediatrics. 2004 Apr;35(2):95-8. doi: 10.1055/s-2004-815830.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interferon Gamma 1-b 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 8 inclusion and 5 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 2017. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change in central macular thickness as measured by OCT as compared with baseline.. 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 NCT00943982, 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 2 Jul 2017.