LUMINATE: A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

Sponsor

Lux Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00404885

Collaborator

(none)

108

Enrollment

Locations

Arms

Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

Condition or Disease	Intervention/Treatment	Phase
Uveitis, Anterior Panuveitis	Drug: Placebo Drug: LX211 Drug: LX211 Drug: LX211	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Anterior Uveitis

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo PO BID
Active Comparator: LX211, 0.2 mg/kg	Drug: LX211 0.2 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.4 mg/kg	Drug: LX211 0.4 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.6 mg/kg	Drug: LX211 0.6 mg/kg, twice a day (BID)

Outcome Measures

Primary Outcome Measures

anterior chamber cells [16 and 24 weeks]

Secondary Outcome Measures

BCVA [24 weeks]
macular thickness [16 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented history of non-infectious anterior, anterior and intermediate- or panuveitis
Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
Grade of 2+ or higher for anterior chamber cells at time of enrollment
Considered by the investigator to require corticosteroid-sparing therapy.
Subjects not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

Uveitis of infectious etiology
Presence of an ocular toxoplasmosis scar
An immune suppression regimen that includes an alkylating agent within the previous 90 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States
2	Retinal Consultants of Arizona	Phoenix	Arizona	United States	85014
3	University of Illinois - Chicago	Chicago	Illinois	United States	60612
4	Wilmer Eye Institute	Baltimore	Maryland	United States	21287
5	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States
6	Massachusetts Eye Research and Surgery Institute	Cambridge	Massachusetts	United States	02142
7	Associated Retinal Consultants, PC	Grand Rapids	Michigan	United States	49546
8	Tauber Eye Center	Kansas City	Missouri	United States	64111
9	New York Eye & Ear Hospital	New York	New York	United States	10003
10	Duke University Eye Center, Erwin Road	Durham	North Carolina	United States
11	Oregon Health Sciences University	Portland	Oregon	United States	97201
12	Brian B. Berger, MD, P.A.	Austin	Texas	United States	78705
13	Retina & Uveitis Consultants of Texas	San Antonio	Texas	United States	78240
14	Viginia Eye Consultants	Norfolk	Virginia	United States	23502
15	Universitätsklinik für Augenheilkunde	Salzburg		Austria
16	Klinik für Augenheilkunde, Dept. of Ophthalmology	Wien		Austria
17	McGill University Health Center	Montreal	Quebec	Canada	H3A 1A1
18	Hôpital Pitié Salpétrière, Service d'Ophtalmologie	Paris		France
19	Universitätsklinikum Freiburg	Freiburg		Germany
20	Augenklinik der Universität Heidelberg	Heidelberg		Germany
21	St. Franziskus-Hospital	Münster		Germany
22	Universitätsklinikum Tübingen	Tübingen		Germany
23	L V Prasad Eye Institute	Hyderabaad	Andhra Pradesh	India
24	Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology	Madurai	Tamil Nadu	India
25	Vittala International Institute of Ophthalmology	Bangalore		India
26	Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)	Chandigarh		India
27	Aravind Eye Hospital, Uvea Clinic	Coimbatore		India
28	Aditya Jyot Eye Hospital Pvt Ltd	Mumbai		India
29	Bristol Eye Hospital and University of Bristol	Bristol		United Kingdom
30	Royal Liverpool University Hospital	Liverpool		United Kingdom