Clinical Trial: Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional



Official Title: Treatment of Non-infectious Panuveitis, Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate

Brief Summary:

BACKGROUND:

Uveitis comprises of a group of diseases associated with inflammation of the eye that can lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, but treatment does not always prevent vision loss. Previous research has shown that injections of methotrexate into the eye of people with eye disease other than uveitis can help relieve the inflammation, or swelling, that causes macular edema and can slow visual loss. However, it has not yet been approved as a treatment for macular edema associated with uveitis.

OBJECTIVES:

To evaluate the safety and effectiveness of methotrexate injections as a treatment for macular edema associated with uveitis.

ELIGIBILITY:

Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema in at least one eye.

DESIGN:

  • This study requires at least nine visits to the National Eye Institute study clinic over a period of 6 months (24 weeks).
  • Participants will be screened with a physical and ophthalmic examination, medical history, blood and urine tests, and additional eye and other tests as needed.
  • Participants will receive a methotrexate injection in a selected treatment eye. After the injection, participants will receive antibiotic eye drops to place in the eye three times a day for the 3 days following the injection, leucovorin (folic acid) drops to place in the eye four ti