Some weeks ago we wrote about a novel treatment trial Involving a relatively old immunosuppressant – sirolimus – being used in a new way as an invitreal injection. https://birdshot.org.uk/sirolimus-eye-injections-given-orphan-drug-status/.
Recently we discovered a similar trial, but this time using a different immunosuppressant – methotrexate – as an invitreal injection.
The trial is looking at people who have chronic macular edema (the American spelling – in the UK we spell it oedema) as a secondary or complication to their Birdshot or other form of intermediate or posterior uveitis. The macular edema must affect at least one eye that has not responded to conventional immunosuppressive therapies over the previous 3 months or has recurred while on conventional immunosuppressive therapies. Methotrexate is injected on a monthly basis for 3 months and then as needed. This trial is openly recruiting in Bethesda USA.
This information might be useful for our American members. If you are interested in more information about it you can contact Patient Recruitment and Public Liaison Office firstname.lastname@example.org (800) 411-1222 TTY 1-866-411-1010
If any of our American members are already on the trial or are thinking of registering for it, we would be really grateful to hear about your experiences. If this therapy proves to be successful, we hope that this will add to the growing range of medications that help us preserve our visual acuity.
Here is a brief summary of the research:-
Uveitis comprises 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. The objective of the study is to evaluate the safety and effectiveness of methotrexate injections as a treatment for macular edema associated with uveitis. 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 full physical and ophthalmic examination, a medical history, blood and urine tests, and additional eye and other tests as needed. An oral dose of folic acid is taken 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.