Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to investigate the safety and efficacy of microplasmin as a treatment for uveitic macular edema.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Eye Institute (NEI)
• Treatments: Fibrinolysin; Plasminogen

Criteria

Inclusion Criteria

1. Participant must be 18 years of age or older.

2. Participant must understand and sign the protocol's informed consent document.

3. Participant has a diagnosis of uveitic macular edema that requires treatment in at least one eye (the study eye) and the uveitis in the study eye is deemed clinically quiet by the investigator.

4. Participant has no evidence of macular or complete PVD in the study eye by B-scan ultrasound and OCT.

5. Participant has visual acuity of 20/400 or better in the study eye.

6. Participant has a central macular thickness ≥ 270 microns in the study eye and loss of the normal foveal contour.

7. Participant does not have significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.

8. Female participants of childbearing potential must not be pregnant or breast-feeding and must have a negative serum pregnancy test at screening and throughout the study.

9. Both female participants of childbearing potential and male participants able to father a child must agree to practice two effective methods of birth control for six months following administration of study medication. Acceptable methods of birth control for this study include hormonal contraception (birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods (diaphragm, condom) with spermicide or surgical sterilization (hysterectomy, tubal ligation or vasectomy). Participants with a hysterectomy or vasectomy (or have a partner with a hysterectomy or vasectomy) are exempt from using two methods of birth control.

10. Participant is willing to comply with the study procedures and return for all study visits.

Exclusion Criteria

1. Participant has uncontrolled glaucoma, defined as intraocular pressure >30 mmHg despite treatment with anti-glaucoma medication, in the study eye.

2. Participant has lattice degeneration of the retina in the study eye deemed to be high risk by the investigator.

3. Participant has untreated retinal holes or tears, or a macular hole in the study eye.

4. Participant has a significant active ocular infection in the study eye.

5. Participant had intraocular surgery within the past 90 days or anticipates elective intraocular surgery in the study eye.

6. Participant had an injection of bevacizumab or ranibizumab within the past four weeks in the study eye.

7. Participant had an injection of triamcinolone within the past six weeks in the study eye.

8. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that would pose a significant hazard if investigational therapy was started).

9. Participant has known anaphylaxis to sodium fluoride, or has urticaria, angioedema or an anaphylactoid response to sodium fluorescein dye that cannot be safely pre-medicated with an antihistamine and/or prednisone.