NCT01376362

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 8, 2012

Completed
Last Updated

October 8, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

June 17, 2011

Results QC Date

August 3, 2012

Last Update Submit

September 6, 2012

Conditions

Anterior UveitisUveitis

Keywords

Cystoid Macular EdemaIntermediate UveitisUveitisOCTInterferon-Gamma (IFN-Gamma)

Outcome Measures

Primary Outcomes (1)

  • Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline

    Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.

    Baseline and 1 Week

Secondary Outcomes (16)

  • Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline

    Baseline and 1 Week

  • Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline

    Baseline and 2 Weeks

  • Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline

    Baseline and 2 Weeks

  • Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline

    Baseline and 1 Week

  • Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline

    Baseline and 1 Week

  • +11 more secondary outcomes

Study Arms (1)

Interferon gamma-1b

EXPERIMENTAL

Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.

Drug: Interferon Gamma-1b

Interventions

Interferon Gamma-1bDRUG

Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.

Also known as: Actimmune®
Interferon gamma-1b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Battle TE, Lynch RA, Frank DA. Signal transducer and activator of transcription 1 activation in endothelial cells is a negative regulator of angiogenesis. Cancer Res. 2006 Apr 1;66(7):3649-57. doi: 10.1158/0008-5472.CAN-05-3612.

    PMID: 16585190BACKGROUND

  • Khorana HG. Rhodopsin, photoreceptor of the rod cell. An emerging pattern for structure and function. J Biol Chem. 1992 Jan 5;267(1):1-4. No abstract available.

    PMID: 1730574BACKGROUND

  • Shi G, Maminishkis A, Banzon T, Jalickee S, Li R, Hammer J, Miller SS. Control of chemokine gradients by the retinal pigment epithelium. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4620-30. doi: 10.1167/iovs.08-1816. Epub 2008 Apr 30.

    PMID: 18450597BACKGROUND

MeSH Terms

Conditions

Uveitis, AnteriorUveitisMacular EdemaUveitis, Intermediate

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

PanuveitisUveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Results Point of Contact

Title
Hatice Nida Sen, Principal Investigator, National Eye Institute
Organization
National Institutes of Health
senh@nei.nih.gov
(301) 402-3254

Study Officials

  • Hatice Nida Sen, MD, MHSc

    National Eye Institute (NEI)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, NEI

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

October 8, 2012

Results First Posted

October 8, 2012

Record last verified: 2012-09

Locations

US(1)