Trial Outcomes & Findings for Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies (NCT NCT02080091)

NCT ID: NCT02080091

Last Updated: 2015-08-26

Results Overview

Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.

• Recruitment status: TERMINATED
• Target enrollment: 25 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2015-08-26

Participant Flow

Participant milestones

Measure	Chronic DME Patients with vision impairment associated with chronic diabetic macular edema (DME)
Overall Study STARTED	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Chronic DME Patients with vision impairment associated with chronic diabetic macular edema (DME)
Overall Study Study Terminated	22
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Other	1

Baseline Characteristics

Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies

Baseline characteristics by cohort

Measure	Chronic DME n=23 Participants Patients with vision impairment associated with chronic diabetic macular edema (DME)
Age, Continuous	67.4 years STANDARD_DEVIATION 9.02 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Germany	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: 23 Patients received ILUVIEN, one patient was treated bilaterally

Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.

Outcome measures

Measure	Chronic DME n=24 Eyes Patients with vision impairment associated with chronic diabetic macular edema (DME)
Visual Acuity	-0.025 LogMAR Standard Error 0.0357

PRIMARY outcome

Timeframe: 24 Months

Population: 23 Patients received ILUVIEN, one patient was treated bilaterally

Outcome measures

Measure	Chronic DME n=24 Eyes Patients with vision impairment associated with chronic diabetic macular edema (DME)
Number of Patients With Ocular Adverse Events	7 participants

SECONDARY outcome

Timeframe: 24 months

Population: 23 Patients received ILUVIEN, one patient was treated bilaterally

Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.

Outcome measures

Measure	Chronic DME n=24 Eyes Patients with vision impairment associated with chronic diabetic macular edema (DME)
Retinal Center Subfield Thickness	357.0 microns Standard Deviation 136.44

Adverse Events

Chronic DME

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chronic DME n=23 participants at risk Patients with vision impairment associated with chronic diabetic macular edema (DME)
Nervous system disorders cerebral hemorrhage	8.7% 2/23 • Number of events 2
Surgical and medical procedures phacoemulsification of left eye	4.3% 1/23 • Number of events 1
Nervous system disorders suspected slight apoplex	4.3% 1/23 • Number of events 1
Nervous system disorders stroke	8.7% 2/23 • Number of events 2

Other adverse events

Measure	Chronic DME n=23 participants at risk Patients with vision impairment associated with chronic diabetic macular edema (DME)
Surgical and medical procedures cataract op on contralateral eye	4.3% 1/23 • Number of events 1
Investigations increase of IOP	4.3% 1/23 • Number of events 3
Eye disorders temporal periphere avascular areals	4.3% 1/23 • Number of events 1
Eye disorders significant worsening of macular edema	4.3% 1/23 • Number of events 1
Eye disorders hemorrhage of vitreous	4.3% 1/23 • Number of events 1
Investigations planned implantation of catheter into atrium	4.3% 1/23 • Number of events 1
Surgical and medical procedures implantation of shunt into left arm	4.3% 1/23 • Number of events 1
Surgical and medical procedures excision of atrium catheter	4.3% 1/23 • Number of events 1
Skin and subcutaneous tissue disorders eczema in face and on elbows	4.3% 1/23 • Number of events 1
Eye disorders hyposphagma	8.7% 2/23 • Number of events 2
Eye disorders conjunctival injection, moderate inflammation in anterior chamber	4.3% 1/23 • Number of events 1
Eye disorders posterior capsular fibrosis	4.3% 1/23 • Number of events 1
Eye disorders epiretinal gliosis	4.3% 1/23 • Number of events 1

Additional Information

Andrew Joyson - Associate Director, Clinical Operations Europe

Alimera Sciences, Ltd.

Phone: +44 1252 354 026

Email: Andrew.Joyson@alimerasciences.com

Results disclosure agreements

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

Restriction type: LTE60