Phase 2 N=5 Treatment

Topical Interferon Gamma for Macular Edema Secondary to Uveitis

Anterior Uveitis · Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT01376362 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline — -38.60 µm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Interferon Gamma-1b (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline	-38.60	—
SECONDARY Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline	12.00	—
SECONDARY Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline	-47.40	—
SECONDARY Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline	30.20	—
SECONDARY Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline	-0.02	—
SECONDARY Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline	0.14	—
SECONDARY Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline	0.00	—
SECONDARY Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline	0.06	—
SECONDARY Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week One Compared to Baseline	0.20	—
SECONDARY Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week One Compared to Baseline	1.60	—
SECONDARY Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week Two Compared to Baseline	4.00	—
SECONDARY Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week Two Compared to Baseline	3.20	—
SECONDARY Change in Intraocular Pressure (IOP) in the Study Eye at Week One Compared to Baseline	0.40	—
SECONDARY Change in Intraocular Pressure (IOP) in the Fellow Eye at Week One Compared to Baseline	-1.60	—
SECONDARY Change in Intraocular Pressure (IOP) in the Study Eye at Week Two Compared to Baseline	0.40	—
SECONDARY Change in Intraocular Pressure (IOP) in the Fellow Eye at Week Two Compared to Baseline	-2.20	—
SECONDARY Proportion of Participants With a Visual Loss of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in the Study Eye	—	—

Summary

The objective of this study is to investigate the safety and efficacy of ocular instillations of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to uveitis.

Eligibility Criteria

Inclusion Criteria

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 CME (central thickness of >275 microns on OCT and/or disruption of foveal contour) secondary to uveitis in at least one eye (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 20/400 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 two acceptable forms of contraception during the study and for six weeks following the last administration of investigational product. 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

Participant is unable to tolerate the ocular instillations or follow study procedures.
Participant has a significant active infection (an infection requiring treatment as determined by the medical team) that in the principal investigator's best medical judgment would preclude participation.
Participant has multiple sclerosis (MS), as interferon gamma may cause MS exacerbations.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01376362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.