Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema (MIME)
|ClinicalTrials.gov Identifier: NCT01194674|
Recruitment Status : Terminated (Lack of enrollment.)
First Posted : September 3, 2010
Results First Posted : August 14, 2012
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Uveitis||Drug: Microplasmin||Phase 1 Phase 2|
Objective: Uveitis, an inflammatory condition that affects the uvea (iris, ciliary body and choroid) and adjacent structures of the eyes, is an important cause of visual loss. Most cases of uveitis, not related to an infectious agent, are thought to be autoimmune in origin and are effectively treated with medications to suppress the function of the immune system. Efforts to decrease morbidity, reduce the dose of more toxic immunosuppressive drugs, reduce the frequency of recurrences of inflammation and its sequelae are important goals in the treatment of uveitis. A frequent sequela of uveitis is macular edema. Treatment of macular edema in patients with uveitis has been a particular challenge. Current evidence from diabetic macular edema (DME) and vitreomacular traction (VMT) trials suggests that pharmacologically-induced vitreoretinal separation could be a potential treatment for macular edema associated with uveitis. Microplasmin, a truncated form of human plasmin and naturally occurring enzyme that dissolves blood clots, may be a reasonable candidate for the treatment of uveitic macular edema. The objective of this study is to investigate the safety and efficacy of microplasmin as a treatment for uveitic macular edema.
Study Population: Five participants with uveitic macular edema, with or without VMT, will be enrolled. In addition, participants must have no evidence of macular or complete posterior vitreous detachment (PVD) by Optical Coherence Tomography (OCT) or ultrasound.
Design: This Phase I-II, non-randomized, prospective, uncontrolled, single-center study will involve a one-time intravitreal injection of 125 µg in 100 µL of microplasmin. Eligible participants can receive the intravitreal injection on the same day of the baseline examination. Participants will be followed for 24 weeks post-injection.
Outcome Measures: The primary outcome measure related to the safety and tolerability of microplasmin will be assessed by the number and severity of adverse events (AEs) and systemic and ocular toxicities during the study. The secondary outcome measures related to the potential efficacy of an intravitreal injection of microplasmin for macular edema secondary to uveitis will be assessed by a change in central macular thickness from baseline measured by OCT in response to microplasmin at 4 and 12 weeks post-injection, the number of participants achieving macular or complete PVD at 4 and 12 weeks post-injection, the change of ETDRS best-corrected visual acuity (BCVA) and the change of retino-vascular leakage from baseline seen on fluorescein angiography (FA).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema|
|Study Start Date :||January 2011|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
- Number of Adverse Events [ Time Frame: 24 weeks ]
- Number of Severe Adverse Events [ Time Frame: 24 weeks ]
- Number of Ocular Adverse Events [ Time Frame: 24 weeks ]The number of eye-related adverse events was calculated.
- Number of Non-ocular Adverse Events [ Time Frame: 24 weeks ]The number of adverse events that were not eye-related was calculated.
- Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline [ Time Frame: Baseline and 4 weeks ]Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
- Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks [ Time Frame: Baseline and 4 weeks ]
- Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline [ Time Frame: Baseline and 4 weeks ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline [ Time Frame: Baseline and 12 Weeks ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline [ Time Frame: Baseline and 4 weeks ]Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194674
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Hatice Nida Sen, MD, MHSc||National Institutes of Health (NIH)|