Phase 2 Study of MM-093 to Treat Patients With Uveitis
|ClinicalTrials.gov Identifier: NCT00444743|
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : December 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Uveitis||Drug: MM-093 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Double - Blind, Placebo - Controlled, Randomized Study to Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of MM-093 in Patients With Moderate to Severe Uveitis|
|Study Start Date :||February 2007|
|Primary Completion Date :||November 2008|
|Active Comparator: 1||
60 mg, administered subcutaneously, weekly
|Placebo Comparator: 2||
- To evaluate the safety and tolerability of MM-093, as compared to placebo, when administered as a monotherapy once a week for 24 weeks after discontinuing IMT therapy.
- To evaluate the biological activity of MM-093, as compared to placebo, as defined by the proportion of patients who have a relapse in their uveitis after discontinuing IMT therapy.
- To evaluate the time to relapse of uveitis after IMT therapy has been discontinued.
- To evaluate the degree of IMT tapering before a recurrence of uveitis occurs.
- To evaluate visual function as evidenced by visual acuity and by electroretinography.
- To evaluate sub clinical inflammation as measured by fluorescein angiography.
- To evaluate the formation of anti-MM-093 antibodies after MM-093 administration.
- To evaluate the formation of anti-goat antibodies after MM-093 administration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444743
|United States, Massachusetts|
|Cambridge, Massachusetts, United States, 02142|
|Principal Investigator:||Dr. Stephen Foster||Massachusetts Eye Research and Surgery Institute|