Phase 2 Study of MM-093 to Treat Patients With Uveitis
This study has been completed.
Information provided by:
First received: March 7, 2007
Last updated: December 16, 2008
Last verified: December 2008
The purpose of this study is to evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Chorioretinitis Uveal Diseases Choroiditis PanuveitisU.S. FDA Resources
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||February 2007|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
60 mg, administered subcutaneously, weekly
|Placebo Comparator: 2||
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444743
|United States, Massachusetts|
|Cambridge, Massachusetts, United States, 02142|
Sponsors and Collaborators
|Principal Investigator:||Dr. Stephen Foster||Massachusetts Eye Research and Surgery Institute|