Explore the NIHProtocol Details
Treatment of Non-infectious Panuveitis, Intermediate and Posterior Uveitis Associated Macular Edema with Intravitreal Methotrexate
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-EI-0107 |
Sponsoring Institute |
National Eye Institute (NEI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Uveitis; |
Recruitment Keyword(s) |
Uveitis; |
Condition(s) |
Non-infectious Intermediate and Posterior Uveitis |
Investigational Drug(s) |
Intravitreal Methotrexate |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Methotrexate |
Supporting Site |
|
- 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 full physical and ophthalmic examination, a 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.
Eligibility
INCLUSION CRITERIA:
-Participant must be 18 years of age or older.
-Participant must understand and sign the protocol's informed consent document.
-Participant is willing to comply with the study procedures and return for all study visits.
-Participant has chronic macular edema secondary to non-infectious panuveritis posterior or intermediate uveitis in at least one eye (the study eye) that has:
- not been responsive to conventional immunosuppressive therapy in the past 3 months;
OR
- recurred while on conventional immunosuppressive therapy.
- Participant has central macular thickness of greater than or equal to 270 microns in the study eye.
- Participant has visual acuity of 20/400 or better (greater than or equal to 19 ETDRS letters) in the study eye.
- Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening and must be willing to undergo serum pregnancy tests throughout the study.
- Both female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for six months after the last study medication injection. Acceptable methods of contraception include:
- hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
- intrauterine device,
- barrier methods (diaphragm, condom) with spermicide, or
- surgical sterilization (tubal ligation).
EXCLUSION CRITERIA:
- Participant is in another investigational study and actively receiving investigational therapy for macular edema.
- Participant has evidence of infectious panuveritis posterior or intermediate uveitis in either eye.
- Participant is expected to need ocular surgery in the study eye during the course of the trial.
- Participant had intraocular surgery in the study eye within the past 90 days.
- Participant had an injection of bevacizumab or ranibizumab within the past four weeks in the study eye.
- Participant had an injection of triamcinolone within the past six weeks in the study eye.
- Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study.
- Participant has significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.
- Participant has a confirmed positive serologic and/or molecular test for HIV-1/2.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Hatice N. Sen, M.D. National Eye Institute (NEI) National Institutes of Health Building 10 Room 10N112 10 Center Drive Bethesda, Maryland 20892 (301) 435-5139 senh@nei.nih.gov |
Patti Sherry, R.N. National Eye Institute (NEI) National Institutes of Health Building 10 Room 10S226 10 Center Drive Bethesda, Maryland 20892 (301) 435-4529 patti.sherry@nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01314417
QUESTIONS?
Contact the Patient Recruitment and Public Liaison Office for:
- Details on how to participate in a study
- Details on how to refer a patient to a study
NIH Clinical Studies Information Request
Contact the Office of Communications for:
- General information about the NIH Clinical Center
Contact the Department Clinical Research Informatics, (DCRI) for:
- Technical questions about Adobe Acrobat and the PDF format
- Technical questions about this web server
