The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma

NCT00943982 | Completed Phase 1

• 2 other identifiers: 09019109-EI-0191
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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....

Conditions

Uveitis

Keywords

Cystoid Macular Edema; Intermediate Uveitis; Uveitis; OCT; Interferon-Gamma (IFN-Gamma)

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Interferon Gamma 1-b DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 15694681 BACKGROUND

• Artuch 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.

  PMID: 12368988 BACKGROUND

• Artuch 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.

  PMID: 15127307 BACKGROUND

MeSH Terms

Conditions

Uveitis; Macular Edema; Uveitis, Intermediate

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: July 17, 2009
• Primary Completion: June 24, 2010
• Study Completion: June 24, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-06-24

Locations

US (1)