Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03097315

Acronym

AZALEA

Enrollment

Registered

2017-03-31

Start date

2017-04-04

Completion date

2018-01-24

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panuveitis, Uveitis, Uveitis, Anterior, Uveitis, Intermediate, Uveitis, Posterior

Keywords

Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone, Choroid, Choroidal Injection, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide

Brief summary

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

Detailed description

This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema. Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Interventions

DRUG4 mg CLS-TA Suprachoriodal Injection

CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior) * ETDRS BCVA score of ≥ 5 letters read in the study eye

Exclusion criteria

* Any active ocular disease or infection in the study eye other than uveitis * Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications. * Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study * Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	Baseline to 24 weeks	Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

Secondary

Measure	Time frame	Description
Mean Intraocular Pressure in the Study Eye	Baseline, 24 Weeks	Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye	Baseline, 24 Weeks	The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = \<1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = \>50 cells. A lower grade represents less inflammation in the eye.
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye	Baseline, 24 Weeks	The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye.
Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye	Baseline, 24 Weeks	The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye.

Countries

United States

Participant flow

Participants by arm

Arm	Count
4 mg CLS-TA Suprachoriodal Injection Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints	38
Total	38

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	4 mg CLS-TA Suprachoriodal Injection
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	13 Participants
Age, Categorical Between 18 and 65 years	25 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 15.8
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	31 Participants
Region of Enrollment United States	38 participants
Sex: Female, Male Female	25 Participants
Sex: Female, Male Male	13 Participants
Type of Uveitis in the Study Eye Anterior uveitis	12 Participants
Type of Uveitis in the Study Eye Intermediate uveitis	15 Participants
Type of Uveitis in the Study Eye Panuveitis	10 Participants
Type of Uveitis in the Study Eye Posterior uveitis	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 38
other Total, other adverse events	24 / 38
serious Total, serious adverse events	1 / 38

Outcome results

Primary

Adverse Events

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

Time frame: Baseline to 24 weeks