NCT02255032

Brief Summary

The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

September 30, 2014

Results QC Date

January 18, 2021

Last Update Submit

January 18, 2021

Conditions

UveitisMacular EdemaUveitis, PosteriorUveitis, AnteriorPanuveitisUveitis, Intermediate

Keywords

uveitismacular edemaUMEposterior uveitisanterior uveitispanuveitisintermediate uveitisnoninfectious uveitistriamcinolone acetonidesuprachoroidal spaceinjectionmicroneedleintravitreal injectioncorticosteroidCMEchoroidretinamicroinjectionSCS

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis

    2 months

Study Arms (2)

4 mg CLS-TA

EXPERIMENTAL

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

Drug: 4 mg CLS-TA

0.8 mg CLS-TA

EXPERIMENTAL

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

Drug: 0.8 mg CLS-TA

Interventions

4 mg CLS-TADRUG

40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

4 mg CLS-TA
0.8 mg CLS-TADRUG

8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

0.8 mg CLS-TA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of noninfectious uveitis
  • diagnosis of macular edema associated with noninfectious uveitis

You may not qualify if:

  • any ocular trauma within the immediate 6 months prior to treatment
  • any photocoagulation or cryotherapy in the 6 months prior to treatment
  • any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
  • any eye diseases other than uveitis and ME that could compromise central visual acuity
  • any previous suprachoroidal injection of triamcinolone acetonide in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Waltham, Massachusetts, 02451, United States

Location

Unknown Facility

Omaha, Nebraska, 68105, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Fargo, North Dakota, 58103, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

UveitisMacular EdemaUveitis, PosteriorUveitis, AnteriorPanuveitisUveitis, IntermediateChoroidal Effusions

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye AbnormalitiesChoroid Diseases

Results Point of Contact

Title
Thomas Ciulla, MD
Organization
Clearside Biomedical, Inc.
thomas.ciulla@clearsidebio.com
(678) 392-2318

Study Officials

  • Thomas Ciulla, MD

    Clearside Biomedical, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 8, 2021

Results First Posted

February 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(11)