Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema (NCT01194674) | Clinical Trial Compass
TerminatedPhase 1/2
Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema
Stopped: Lack of enrollment.
United States2 participantsStarted 2011-01
Plain-language summary
The objective of this study is to investigate the safety and efficacy of microplasmin as a treatment for uveitic macular edema.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 years of age or older.
✓. Participant must understand and sign the protocol's informed consent document.
✓. 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.
✓. Participant has no evidence of macular or complete PVD in the study eye by B-scan ultrasound and OCT.
✓. Participant has visual acuity of 20/400 or better in the study eye.
✓. Participant has a central macular thickness ≥ 270 microns in the study eye and loss of the normal foveal contour.
✓. Participant does not have significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.
✓. 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.
Exclusion criteria
✕. Participant has uncontrolled glaucoma, defined as intraocular pressure \>30 mmHg despite treatment with anti-glaucoma medication, in the study eye.
✕. Participant has lattice degeneration of the retina in the study eye deemed to be high risk by the investigator.
✕. Participant has untreated retinal holes or tears, or a macular hole in the study eye.
What they're measuring
1
Number of Adverse Events
Timeframe: 24 weeks
2
Number of Severe Adverse Events
Timeframe: 24 weeks
3
Number of Ocular Adverse Events
Timeframe: 24 weeks
4
Number of Non-ocular Adverse Events
Timeframe: 24 weeks
Trial details
NCT IDNCT01194674
SponsorNational Institutes of Health Clinical Center (CC)
✕. Participant has a significant active ocular infection in the study eye.
✕. Participant had intraocular surgery within the past 90 days or anticipates elective intraocular surgery in the study eye.
✕. 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 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).