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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001533-37 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprachoroidal Triamcinolone acetonide 2.4mg | Experimental | 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. |
|
| Suprachoroidal Triamcinolone acetonide 4.0mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide | Drug | Single suprachoroidal Administration of Triamcinolone acetonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 0 up to Week 24 (per protocol individual trial duration per participant) |
| 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) | Day 0 up to Week 24 (per protocol individual trial duration per participant) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Week 4, Week 12, and Week 24 |
| Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Asmus, MD | Oxular Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| Retina Consultants of Minnesota |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population (all subjects eligible and randomized)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event | Posted | Count of Participants | Participants | Day 0 up to Week 24 (per protocol individual trial duration per participant) |
|
Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Friedrich Asmus, MD | Oxular Limited | '+1 631 292 1207 | friedrich.asmus@oxular.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2023 | Oct 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Oct 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Parallel Two-Dose Group Assignment
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Subjects will be masked to the dose level of triamcinolone acetonide administered with the suprachoroidal Oxulumis® microcatheter
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| Semi-automated Suprachoroidal Microcatheter | Device | Ophthalmic Adminstration Device |
|
|
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. |
| Baseline, Week 4, Week 12, and Week 24 |
| 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. | Baseline, Week 4, Week 12, and Week 24 |
| 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 | Baseline, Week 4, Week12, and Week 24 |
| Minneapolis |
| Minnesota |
| 55435 |
| United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas - The Woodlands | Houston | Texas | 77384 | United States |
| Retina Consultants of Texas - Bellaire | Houston | Texas | 77401 | United States |
| Retina Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | United States |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes Type | Count of Participants | Participants |
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| Duration of Diabetes (years) | Mean | Full Range | years |
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| Duration of DME (years), mean (min-max) | Mean | Full Range | years |
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| Lens status, n (%) (Study Eye) | Clinical Examination, e.g. using a Slit Lamp to inspect the ocular lens. Categories are aphakic (no lens present), phakic (lens present), pseudophakic (artificial lens, typically after cataract surgery for lens replacement). | Number | participants |
|
| Central Subfield Thickness (Study Eye) | assessed at the Baseline Visit before treatment | for the efficacy evaluable population with completed administration of trial treatment | Mean | Standard Deviation | µm |
|
| ETDRS BCVA, mean (SD) (Study Eye) | based on duplicate assessment of BCVA at the respective visit, here the Baseline Visit before treatment | for the Efficacy Evaluable Population with completed administration of trial treatment | Mean | Standard Deviation | ETDRS letters |
|
| IOP (mmHg), mean (SD) (Study Eye) | assessed at the Baseline Visit before treatment | Mean | Standard Deviation | mmHg |
|
| OG001 | 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 |
|
|
| 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) | Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event | Posted | Count of Participants | Participants | Day 0 up to Week 24 (per protocol individual trial duration per participant) |
|
|
|
| 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 | Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4, Week 12, and Week 24 |
|
|
|
| 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. | Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye | Posted | Mean | Standard Deviation | µm | Baseline, Week 4, Week 12, and Week 24 |
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| 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. | Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye | Posted | Mean | Standard Deviation | ETDRS letters | Baseline, Week 4, Week 12, and Week 24 |
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|
|
| 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 | 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. | Posted | Count of Participants | Participants | No | Baseline, Week 4, Week12, and Week 24 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 12 |
| 13 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 9 | 12 |
| Blepharitis - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cataract - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Conjunctival Oedema - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Conjunctival haemorrhage - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Conjunctival hyperemia - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Corneal abrasion - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Episcleritis - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Eyelid Ptosis - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Eye Pain - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Retinal Hemorrhage - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vitreous Detachment - Study eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vitreous hemorrhage - Study Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Treatment Failure (Trial procedure not completed in the study eye) | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Conjunctival laceration - Study Eye | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Underdose - Treatment Study Eye | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Wrong route - Treatment Study Eye | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Intraocular pressure increased - Study Eye | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Prostate-specific antigen increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Benign prostate hyperplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vitreous Detachment - Fellow Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cataract - Fellow Eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Mean Change in IOP from Baseline at Week 12 |
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| Mean Change in IOP from Baseline at Week 24 |
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| Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline |
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| Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline |
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| Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline |
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| Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline |
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| Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline |
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| Week 24 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline |
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