Trial Outcomes & Findings for Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone (NCT NCT01892163)

NCT ID: NCT01892163

Last Updated: 2017-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2017-02-23

Participant Flow

Participant milestones

Measure	Ozurdex PRN Dosing Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing Ozurdex: Dexamethasone implant (Ozurdex)
Overall Study STARTED	50	50
Overall Study COMPLETED	48	49
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Ozurdex PRN Dosing Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing Ozurdex: Dexamethasone implant (Ozurdex)
Overall Study Death	1	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone

Baseline characteristics by cohort

Measure	Ozurdex PRN Dosing n=50 Participants Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=50 Participants Ozurdex: Dexamethasone implant (Ozurdex)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	25 Participants n=4 Participants	45 Participants n=27 Participants
Age, Categorical >=65 years	30 Participants n=93 Participants	25 Participants n=4 Participants	55 Participants n=27 Participants
Age, Continuous	65.4 years STANDARD_DEVIATION 9.8 • n=93 Participants	63.8 years STANDARD_DEVIATION 11.1 • n=4 Participants	64.6 years STANDARD_DEVIATION 10.5 • n=27 Participants
Gender Female	16 Participants n=93 Participants	10 Participants n=4 Participants	26 Participants n=27 Participants
Gender Male	34 Participants n=93 Participants	40 Participants n=4 Participants	74 Participants n=27 Participants
Region of Enrollment United Kingdom	50 participants n=93 Participants	50 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Intention to treat analysis (available case)

Outcome measures

Measure	Ozurdex PRN Dosing n=48 Participants Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=49 Participants Ozurdex: Dexamethasone implant (Ozurdex)
The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months	0 ETDRS letters Standard Deviation 13.0	0.53 ETDRS letters Standard Deviation 16.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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

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

Outcome measures

Measure	Ozurdex PRN Dosing n=47 Participants Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=49 Participants Ozurdex: Dexamethasone implant (Ozurdex)
Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).	-0.45 units on a scale Standard Deviation 12.2	3.02 units on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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.

Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns

Outcome measures

Measure	Ozurdex PRN Dosing n=47 Participants Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=47 Participants Ozurdex: Dexamethasone implant (Ozurdex)
Difference Between Arms in Change in Central Subfield Thickness.	-90.1 microns Standard Deviation 96.2	-179.9 microns Standard Deviation 172.4

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Ozurdex PRN Dosing n=50 Participants Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=50 Participants Ozurdex: Dexamethasone implant (Ozurdex)
Proportion of Patients With Ocular and Systemic Serious Adverse Events	10 participants	9 participants

Adverse Events

Ozurdex PRN Dosing

Serious events: 10 serious events

Other events: 13 other events

Deaths: 0 deaths

Ozurdex Fixed Dosing

Serious events: 9 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ozurdex PRN Dosing n=50 participants at risk Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=50 participants at risk Ozurdex: Dexamethasone implant (Ozurdex)
Vascular disorders Death	2.0% 1/50 • 1 year (between baseline and exit)	2.0% 1/50 • 1 year (between baseline and exit)
Eye disorders Retinal Detachment	0.00% 0/50 • 1 year (between baseline and exit)	2.0% 1/50 • 1 year (between baseline and exit)
Eye disorders cataract surgery in study eye	8.0% 4/50 • 1 year (between baseline and exit)	2.0% 1/50 • 1 year (between baseline and exit)
Eye disorders Endophthalmitis	2.0% 1/50 • 1 year (between baseline and exit)	0.00% 0/50 • 1 year (between baseline and exit)
Eye disorders Other non specific eye problems	2.0% 1/50 • 1 year (between baseline and exit)	2.0% 1/50 • 1 year (between baseline and exit)
Cardiac disorders other non ocular events	6.0% 3/50 • Number of events 3 • 1 year (between baseline and exit)	10.0% 5/50 • Number of events 5 • 1 year (between baseline and exit)

Other adverse events

Measure	Ozurdex PRN Dosing n=50 participants at risk Ozurdex PRN dosing versus Ozurdex fixed dosing Ozurdex: Dexamethasone implant (Ozurdex)	Ozurdex Fixed Dosing n=50 participants at risk Ozurdex: Dexamethasone implant (Ozurdex)
Eye disorders Raised Intraocular Pressure	26.0% 13/50 • Number of events 13 • 1 year (between baseline and exit)	16.0% 8/50 • Number of events 8 • 1 year (between baseline and exit)
Eye disorders vitreous haemorrhage	6.0% 3/50 • 1 year (between baseline and exit)	6.0% 3/50 • 1 year (between baseline and exit)
Eye disorders cataract progresion	14.0% 7/50 • 1 year (between baseline and exit)	10.0% 5/50 • 1 year (between baseline and exit)

Additional Information

Professor Sobha Sivaprasad

Moorfields Eye Hospital NHS Foundation Trust

Phone: 02072533411

Email: sobha.sivaprasad@moorfields.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place