A Phase 1/2 interventional study of triamcinolone acetonide (Triesence®) in Uveitis, Intermediate Uveitis and Posterior Uveitis, sponsored by Clearside Biomedical, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Clearside Biomedical, Inc. · Phase 1/2, Interventional, and Treatment
This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 11 is below the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)
Drug: triamcinolone acetonide (Triesence®)
4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Also known as: triamcinolone acetonide, TA, Triesence, corticosteroid
Change in Intraocular Pressure (IOP)
Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.
Time frame: Change from baseline in IOP at 8 weeks
Best Corrected Visual Acuity
Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.
Time frame: Change from baseline at 8 weeks and 26 weeks.
Central Subfield Thickness Using Optical Coherence Tomography (OCT)
Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
Time frame: Change from baseline at 8 weeks and 26 weeks.
Vitreous Haze Grade
Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 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), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.
Time frame: Change from baseline at 8 weeks and 26 weeks
| Milestone | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Started | 11 |
| Completed | 9 |
| Not completed | 2 |
| Withdrew: Re-enrolled into study | 1 |
| Withdrew: Lost to follow-up | 1 |
Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.
| mm Hg | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Change in Intraocular Pressure (IOP) | -0.1 ± 3.21 |
Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.
| logMAR | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Week 8 | -0.25 ± 0.107 |
| Week 26 | -0.28 ± 0.096 |
Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
| Microns | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Week 8 | -153.7 ± 109.45 |
| Week 26 | -107.0 ± 86.95 |
Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 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), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.
| score on a scale | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Week 8 | -0.75 ± 0.463 |
| Week 26 | -0.75 ± 0.289 |
Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triamcinolone Acetonide (Triesence®) | 0/11 (0%) | 1/11 (9.1%) | 11/11 (100%) |
| Event | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/11 |
| Event | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Eye painEye disorders | 5/11 |
| Cystoid macular oedemaEye disorders | 3/11 |
| Visual acuity reducedEye disorders | 2/11 |
| Localised infectionInfections and infestations | 2/11 |
| HeadacheNervous system disorders | 2/11 |
| CataractEye disorders | 1/11 |
| Cystoid macular oedemaEye disorders | 1/11 |
| Eye irritationEye disorders | 1/11 |
| Eyelid margin crustingEye disorders | 1/11 |
| Punctate keratitisEye disorders | 1/11 |
All subjects who received at least one attempted dose of study drug.
| Age, Categorical(Participants) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 1 |
| Age, Continuous(years) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Mean | 57.3 ± 9.47 |
| Sex: Female, Male(Participants) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Female | 8 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Triamcinolone Acetonide (Triesence®) |
|---|---|
| United States | 11 |
The record gives a start of Feb 2013, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2021, 5 years 11 months after primary completion. A results delay was requested in Jul 2016.
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Studies of the drug tested here: Triamcinolone Acetonide
Clearside Biomedical, Inc.