The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Ocular, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | June 2010 |
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....
- 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....
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.
(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.
- INCLUSION CRITERIA:
1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol's informed consent document.
3. 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).
4. Participant has a central macular thickness greater than or equal to 250 microns
in the study eye.
5. Participant is willing to comply with the study procedures and is expected to be
able to return for all study visits.
6. Participant has visual acuity of 20/200 or better in the study eye.
7. Female participants of childbearing potential must not be pregnant or
breast-feeding.
8. 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).
EXCLUSION CRITERIA:
1. Participant is expected to be unable to tolerate the ocular instillation.
2. Participant is unable to undergo OCT testing.
3. Participant had herpes keratitis in the past.
4. Participant is diagnosed with multiple sclerosis.
5. 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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