Clinical trial NCT02952001: MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Official title: MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Uveitis, Posterior
Uveitis, Anterior
Uveitis, Intermediate
Panuveitis
Keywords: Uveitis
UME
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Panuveitis
Non-infectious Uveitis
Triamcinolone
Choroid
Choroidal Injection
Suprachoroidal
Microneedle
Microinjection
Triamcinolone acetonide
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include approximately 30 adult subjects that successfully complete the Parent study without requiring additional therapy to treat symptoms for uveitis as defined by the protocol.

Brief summary: This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.

Detailed description: This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

The design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).

This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
* Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits

Exclusion Criteria:

* Received additional therapy for the treatment of uveitis or prohibited medication
* Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit

Primary outcomes:
measure: Time to Additional Therapy for Uveitis
timeFrame: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
timeFrame: 6 months following exit from Parent study
measure: Mean Change From Baseline in Central Subfield Thickness
timeFrame: 6 months following exit from Parent study
measure: Mean Change From Baseline in Best Corrected Visual Acuity
timeFrame: 6 months following exit from Parent study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons, PC
state: Massachusetts
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Portland
country: United States
facility: Oregon Health & Science University Casey Eye Institute
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Eye Center
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Guwahati
country: India
facility: Sri Sankaradeva Nethralaya
state: Assam
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Coimbatore
country: India
facility: Sankara Eye Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Kolkata
country: India
facility: Disha Eye Hospitals Pvt. Ltd.
city: New Delhi
country: India
facility: Dr Rajendra Prasad Centre for Ophthalmic Sciences
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References: