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A Phase I/II Study to Investigate Subconjunctival Sirolimus for the Treatment of Active Autoimmune Non-Necrotizing Anterior Scleritis
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
12-EI-0057 |
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 |
Sirolimus; |
Recruitment Keyword(s) |
Autoimmune Scleritis; |
Condition(s) |
Scleritis |
Investigational Drug(s) |
Sirolimus |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Sirolimus |
Supporting Site |
|
- Autoimmune scleritis is an inflammatory disease that affects the white outer part of the eye. It is associated with immune system disorders like rheumatoid arthritis. It can cause blindness in severe cases. Most treatments for scleritis involve steroid or immune-suppressing drugs, but these can cause side effects in the whole body.
- Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune system from attacking the body. Researchers want to try giving sirolimus injections into the eye to treat severe scleritis.
Objectives:
- To see if sirolimus is a safe and effective treatment for autoimmune scleritis.
Eligibility:
- Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has not responded to standard treatments.
Design:
- Participants will be screened with a medical history, physical exam, and eye exam. Blood and urine samples will also be collected.
- One eye will be selected as the study eye to receive injections.
- Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8, 12, and 16). The injection will be given at the first visit. If the study eye responds to the treatment, participants may have injections in the other eye at the second visit.
- If there is still inflammation after the first injection, or if the scleritis improves but then returns, participants may have a second injection at Week 4.
- Treatment will be monitored with blood tests and eye exams.
- Participants may have study visits and injections for up to 1 year if the treatment seems to be working.
Eligibility
INCLUSION CRITERIA:1. Participant has the ability to understand and sign the informed consent document.
2. Participant is 18 years of age or older.
3. Participant has a diagnosis of active, autoimmune, non-necrotizing, anterior scleritis.
4. Participant, if currently taking immunosuppressive medications, is on a stable regimen of immunosuppressive medications (no increase and/or start of new immunosuppressive medications) over the last four weeks.
5. Participant has tried therapy such as oral NSAIDs, or oral or topical corticosteroids or immunosuppressive medication at any time in the past to control scleritis flares, or has intolerance or contraindications to these medications.
6. Participant is willing and able to comply with the study procedures.
7. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
8. Both female participants of childbearing potential (see Appendix 1 for definition) 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 four months after the last investigational product 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:
1. Participant has a significant active intraocular infection in either eye that requires antibiotic treatment.
2. Participant has an active serious infection or a history of recurring serious infections such as human immunodeficiency virus (HIV) or syphilis that in the best medical judgment of the investigators would pose unnecessary risk to the participant.
3. Participant has active joint or systemic inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
4. Participant is taking systemic azole anti-fungal medication (e.g., ketoconazole, voriconazole, itraconazole).
STUDY EYE ELIGIBILITY CRITERIA:
The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
STUDY EYE INCLUSION CRITERIA:
1. Participant has anterior scleritis with greater than or equal to 1 plus in at least one quadrant of the study eye.
2. Participant has visual acuity in the study eye of 20/640 or better.
Participant agrees not to undergo elective intraocular surgery in the study eye (e.g., cataract extraction) for three months after the last injection.
4. Participant has not received a periocular or intravitreal injection in the study eye in the last six weeks.
STUDY EYE EXCLUSION CRITERIA:
1. Participant has necrotizing scleritis in the study eye.
2. Participant had intraocular surgery in the study eye in the last four weeks.
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 |
Dominic Obiyor, R.N. National Eye Institute (NEI) National Institutes of Health Building 10 Room 10D457 10 Center Drive Bethesda, Maryland 20892 (301) 435-4556 dobiyor@mail.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:
NCT01517074
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