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| Name | Class |
|---|---|
| The Royal Wolverhampton Hospitals NHS Trust | OTHER_GOV |
| Frimley Park Hospital NHS Trust | OTHER |
| Brighton and Sussex University Hospitals NHS Trust | OTHER |
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Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex PRN dosing | Active Comparator | Ozurdex PRN dosing versus Ozurdex fixed dosing |
|
| Ozurdex fixed dosing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Device | Dexamethasone implant (Ozurdex) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25). | NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest). Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sobha Sivaprasad, FRCS | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation trust | London | EC1V 2PD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex PRN Dosing | Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex) |
| FG001 | Ozurdex Fixed Dosing | Ozurdex: Dexamethasone implant (Ozurdex) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex PRN Dosing | Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex) |
| BG001 | Ozurdex Fixed Dosing | Ozurdex: Dexamethasone implant (Ozurdex) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months | Intention to treat analysis (available case) | Posted | Mean | Standard Deviation | ETDRS letters | Baseline and 12 months |
|
|
1 year (between baseline and exit)
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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 | Ozurdex PRN Dosing | Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Raised Intraocular Pressure | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Sobha Sivaprasad | Moorfields Eye Hospital NHS Foundation Trust | 02072533411 | sobha.sivaprasad@moorfields.nhs.uk |
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| University Hospitals Bristol and Weston NHS Foundation Trust |
| OTHER |
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| Baseline and 12 months |
| Difference Between Arms in Change in Central Subfield Thickness. | Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns | Baseline and 12 months |
| Proportion of Patients With Ocular and Systemic Serious Adverse Events | 12 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25). | NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest). Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score | Though 48 patients completed the trial in the PRN arm, one patient did not complete the questionnaire completely, making it invalid for analysis. Hence the PRN arm number for this outcome was 47 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
| Secondary | Difference Between Arms in Change in Central Subfield Thickness. | Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns | Few patients in both groups developed cataract. Due to the dense cataract, it was not possible to obtain the macular scans. Hence the discrepancy between the population who completed the study and the number for whom the OCT was obtained at exit visit. | Posted | Mean | Standard Deviation | microns | Baseline and 12 months |
|
|
|
| Secondary | Proportion of Patients With Ocular and Systemic Serious Adverse Events | Posted | Number | participants | 12 months |
|
|
|
| 10 |
| 50 |
| 13 |
| 50 |
| EG001 | Ozurdex Fixed Dosing | Ozurdex: Dexamethasone implant (Ozurdex) | 9 | 50 | 8 | 50 |
| Retinal Detachment | Eye disorders | Systematic Assessment |
|
| cataract surgery in study eye | Eye disorders | Systematic Assessment |
|
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
| Other non specific eye problems | Eye disorders | Systematic Assessment |
|
| other non ocular events | Cardiac disorders | Systematic Assessment |
|
| vitreous haemorrhage | Eye disorders | Systematic Assessment |
|
| cataract progresion | Eye disorders | Systematic Assessment |
|
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