Diabetic Macular Edema
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
Detailed description
Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema. After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be treated using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached. From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.
Interventions
DRUGTriamcinolone Acetonide
Single suprachoroidal Administration of Triamcinolone acetonide
DEVICESemi-automated Suprachoroidal Microcatheter
Ophthalmic Adminstration Device
Sponsors
Oxular Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be masked to the dose level of triamcinolone acetonide administered with the suprachoroidal Oxulumis® microcatheter
Intervention model description
Parallel Two-Dose Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or Type 2 diabetes mellitus. * Diabetic macular edema involving the center of the fovea in the study eye * Best-corrected visual acuity in the study eye of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse) * Short-lived, limited, or no response to prior ocular injection therapy
Exclusion criteria
* Macular edema is considered due to a cause other than diabetes mellitus in the study eye. * Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema * Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within sixteen (16) weeks prior to screening. * Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye. * Active malignancy or history of malignancy within the past five years. * Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening * Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening. * Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary. * Prior treatment with suprachoroidal steroids is exclusionary. * Uncontrolled diabetes with a hemoglobin A1c (HbA1c) \> 12% or any other uncontrolled systemic disease at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Day 0 up to Week 24 (per protocol individual trial duration per participant) | Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0) |
| Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects | Day 0 up to Week 24 (per protocol individual trial duration per participant) | Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in IOP Through Week 24 Compared to Baseline | Baseline, Week 4, Week 12, and Week 24 | Change from baseline in intraocular pressure as measured by applanation tonometry or standard IOP measuring devices |
| Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Baseline, Week 4, Week 12, and Week 24 | Change from Baseline in central subfield thickness (CST), to image the macular edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT) and was read at the site. A negative change from baseline value represents a reduction in macular edema. |
| Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Baseline, Week 4, Week 12, and Week 24 | Best corrected visual acuity (BCVA) using the ETDDRS methodology) with assessment starting at a distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity. |
| Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Baseline, Week 4, Week12, and Week 24 | Measure Description: Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity. The Outcome Measure provides the number of participants, who have at least a 5, 10, or 15 letter BCVA gain at the respective study visit compared to their baseline BCVA assessment |
Countries
United States
Participant flow
Recruitment details
Consecutive recruitment at participating sites in the US. Enrolment will be continued, until at least 20 randomized subjects could also be treated, i.e. total enrolment could be higher than 20.
Participants by arm
| Arm | Count |
|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device | 13 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Suprachoroidal Triamcinolone Acetonide 4.0mg | Total | Suprachoroidal Triamcinolone Acetonide 2.4mg |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 6.78 | 63.0 years STANDARD_DEVIATION 7.46 | 62.8 years STANDARD_DEVIATION 8.32 |
| Central Subfield Thickness (Study Eye) | 560.4 µm STANDARD_DEVIATION 166.8 | 544.7 µm STANDARD_DEVIATION 145.7 | 530.2 µm STANDARD_DEVIATION 128.2 |
| Diabetes Type Type 1 | 0 Participants | 1 Participants | 1 Participants |
| Diabetes Type Type 2 | 12 Participants | 24 Participants | 12 Participants |
| Duration of Diabetes (years) | 20.3 years | 19.9 years | 19.4 years |
| Duration of DME (years), mean (min-max) | 4.2 years | 3.4 years | 2.7 years |
| ETDRS BCVA, mean (SD) (Study Eye) | 52.9 ETDRS letters STANDARD_DEVIATION 14.2 | 57.1 ETDRS letters STANDARD_DEVIATION 13.7 | 60.9 ETDRS letters STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| IOP (mmHg), mean (SD) (Study Eye) | 16.1 mmHg STANDARD_DEVIATION 3.34 | 16.1 mmHg STANDARD_DEVIATION 3.15 | 16.2 mmHg STANDARD_DEVIATION 3.11 |
| Lens status, n (%) (Study Eye) Aphakic (no lens present) | 0 participants | 0 participants | 0 participants |
| Lens status, n (%) (Study Eye) Phakic (lens present) | 5 participants | 13 participants | 8 participants |
| Lens status, n (%) (Study Eye) Pseudophakic (artificial lens present) | 7 participants | 12 participants | 5 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 23 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 25 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 12 / 13 | 9 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Population: Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects | Number of Participants with Adverse Device Effects | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects | Number of Participants with Serious Adverse Device Effects | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects | Number of Participants with Adverse Device Effects | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects | Number of Participants with Serious Adverse Device Effects | 0 Participants |
Primary
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Population: Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Ocular Treatment-Emergent Adverse Events | 10 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Adverse Events | 3 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Ocular Treatment-Emergent Serious Adverse Events | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Serious Adverse Events | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Serious Adverse Events | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Ocular Treatment-Emergent Adverse Events | 8 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Ocular Treatment-Emergent Serious Adverse Events | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events | Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Adverse Events | 5 Participants |
Other Pre-specified
Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
Best corrected visual acuity (BCVA) using the ETDDRS methodology) with assessment starting at a distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Time frame: Baseline, Week 4, Week 12, and Week 24
Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 4 Compared to Baseline | 4.5 ETDRS letters | Standard Deviation 4.7 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline | 0.9 ETDRS letters | Standard Deviation 6 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline | 4.8 ETDRS letters | Standard Deviation 11.8 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 4 Compared to Baseline | 10.6 ETDRS letters | Standard Deviation 10 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline | 9.0 ETDRS letters | Standard Deviation 9.6 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline | Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline | 11.0 ETDRS letters | Standard Deviation 11.5 |
Other Pre-specified
Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
Change from Baseline in central subfield thickness (CST), to image the macular edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT) and was read at the site. A negative change from baseline value represents a reduction in macular edema.
Time frame: Baseline, Week 4, Week 12, and Week 24
Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 4 compared to baseline | -112.3 µm | Standard Deviation 136.2 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline | -63.3 µm | Standard Deviation 71.4 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline | -62.5 µm | Standard Deviation 45 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 4 compared to baseline | -172.0 µm | Standard Deviation 234.1 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline | -132.8 µm | Standard Deviation 133.6 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline | Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline | -127.7 µm | Standard Deviation 198.2 |
Other Pre-specified
Mean Change in IOP Through Week 24 Compared to Baseline
Change from baseline in intraocular pressure as measured by applanation tonometry or standard IOP measuring devices
Time frame: Baseline, Week 4, Week 12, and Week 24
Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 4 | 1.6 mmHg | Standard Deviation 5 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 12 | 1.6 mmHg | Standard Deviation 2.9 |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 24 | 1.3 mmHg | Standard Deviation 2.1 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 4 | 1.0 mmHg | Standard Deviation 2.5 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 12 | -0.2 mmHg | Standard Deviation 4.4 |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Mean Change in IOP Through Week 24 Compared to Baseline | Mean Change in IOP from Baseline at Week 24 | 2.0 mmHg | Standard Deviation 3.6 |
Other Pre-specified
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Measure Description: Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity. The Outcome Measure provides the number of participants, who have at least a 5, 10, or 15 letter BCVA gain at the respective study visit compared to their baseline BCVA assessment
Time frame: Baseline, Week 4, Week12, and Week 24
Population: Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 5 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 1 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 1 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 1 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 2.4mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 0 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 3 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 6 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 1 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 3 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline | 2 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline | 1 Participants |
| Suprachoroidal Triamcinolone Acetonide 4.0mg | Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24 | Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline | 5 Participants |