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
To evaluate the safety and effectiveness of methotrexate injections as a treatment for
macular edema associated with uveitis.
Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema
in at least one eye.
- 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 times a day for 1 week following the injection, and a dose of
folic acid to be taken by mouth the day after the injection.
- Participants who tolerate the initial injection may continue to receive injections in
their study eye every month for 6 months. After 6 months, participants who show
improvement from the injections may be evaluated to receive additional injections every
4 to 8 weeks until researchers end the study.