NCT02303184

Brief Summary

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

14 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

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4.9 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

November 25, 2014

Results QC Date

January 18, 2021

Last Update Submit

January 18, 2021

Conditions

Macular EdemaRetinal Vein Occlusion

Keywords

RVOMECentral Subfield ThicknessOCToptical coherence tomographycystoid macular edemasubretinal fluidEyleaafliberceptanti-VEGF

Outcome Measures

Primary Outcomes (1)

  • Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm

    3 months

Study Arms (2)

4 mg CLS-TA + IVT aflibercept

EXPERIMENTAL

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept

Drug: 4 mg CLS-TADrug: IVT aflibercept

sham + IVT aflibercept

ACTIVE COMPARATOR

Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Drug: ShamDrug: IVT aflibercept

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 + IVT aflibercept
ShamDRUG

suprachoroidal sham procedure

Also known as: suprachoroidal sham
sham + IVT aflibercept
IVT afliberceptDRUG

2 mg intravitreal injection of aflibercept

Also known as: Eylea
4 mg CLS-TA + IVT afliberceptsham + IVT aflibercept

Eligibility Criteria

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

You may qualify if:

  • diagnosis of macular edema following RVO
  • History of ME ≤ 12 months
  • letters inclusive BCVA using ETDRS

You may not qualify if:

  • has had an IVT injection of anti-VEGF for RVO in the study eye
  • has had a corticosteroid injection in the past 3 months in the study eye
  • any uncontrolled ophthalmic condition in the study eye other than RVO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Phoenix, Arizona, 85014, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

San Diego, California, 92037, United States

Location

Unknown Facility

Boynton Beach, Florida, 33426, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

St Louis, Missouri, 63128, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Rapid City, South Dakota, 57701, United States

Location

Unknown Facility

Abilene, Texas, 79606, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

McAllen, Texas, 78503, United States

Location

Unknown Facility

San Antonio, Texas, 78251, United States

Location

Unknown Facility

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

salicylhydroxamic acidaflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular 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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 8, 2021

Results First Posted

February 8, 2021

Record last verified: 2021-01

Locations

US(14)