Trial Outcomes & Findings for A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy (NCT NCT02472366)

NCT ID: NCT02472366

Last Updated: 2015-09-16

Results Overview

Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Change from Baseline to 12 months post ILUVIEN administration
• Results posted on: 2015-09-16

Participant Flow

Participant milestones

Measure	Laser laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Overall Study STARTED	6	10
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Laser laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy

Baseline characteristics by cohort

Measure	Laser n=6 Participants laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 Participants laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN	Total n=16 Participants Total of all reporting groups
Age, Continuous	66.65 years STANDARD_DEVIATION 9.014 • n=5 Participants	60.87 years STANDARD_DEVIATION 11.006 • n=7 Participants	63.04 years STANDARD_DEVIATION 10.398 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 12 months post ILUVIEN administration

Population: For the "Laser" arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN

Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.

Outcome measures

Measure	Laser n=7 Eyes laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 Eyes laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Changes in Best Corrected Visual Acuity From Baseline	3.5 Best Corrected VA Letter Score Standard Deviation 7.40	0.9 Best Corrected VA Letter Score Standard Deviation 15.79

SECONDARY outcome

Timeframe: Change from Baseline to 12 months post ILUVIEN administration

Population: for "laser" arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN

Outcome measures

Measure	Laser n=7 Eyes laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 Eyes laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Changes in Intraocular Pressure (IOP)	1.7 mmHg Standard Deviation 1.86	2.9 mmHg Standard Deviation 6.28

SECONDARY outcome

Timeframe: Change from Baseline to 12 months post ILUVIEN administration

Population: For "Laser" arm group, there were 6 patients enrolled but 7 eyes treated

Outcome measures

Measure	Laser n=7 Eyes laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 Eyes laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Changes in Central Subfield Thickness	-362.2 microns Standard Deviation 130.59	-251.3 microns Standard Deviation 268.29

SECONDARY outcome

Timeframe: Change from Baseline to 12 months post ILUVIEN administration

Population: For "laser" arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN

Outcome measures

Measure	Laser n=7 Eyes laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 Eyes laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Changes in Macular Volume	-1.610 mm^3 Standard Deviation 1.1979	-1.137 mm^3 Standard Deviation 3.4345

POST_HOC outcome

Timeframe: Change from Baseline to 12 months post ILUVIEN administration

Population: For the "Laser" arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN

A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.

Outcome measures

Measure	Laser n=7 Eyes laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=5 Eyes laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Change in Best Corrected Visual Acuity From Baseline	5.6 Best Corrected VA Letter Score Standard Deviation 8.70	9.4 Best Corrected VA Letter Score Standard Deviation 11.46

Adverse Events

Laser

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Laser and Anti-VEGF

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Laser n=6 participants at risk laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 participants at risk laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Nervous system disorders Stroke	0.00% 0/6 • The safety and tolerability of ILUVIEN was monitored over 12 months.	10.0% 1/10 • Number of events 1 • The safety and tolerability of ILUVIEN was monitored over 12 months.
Surgical and medical procedures Cataract Surgery	0.00% 0/6 • The safety and tolerability of ILUVIEN was monitored over 12 months.	10.0% 1/10 • Number of events 2 • The safety and tolerability of ILUVIEN was monitored over 12 months.
Surgical and medical procedures Vitrectomy	0.00% 0/6 • The safety and tolerability of ILUVIEN was monitored over 12 months.	10.0% 1/10 • Number of events 1 • The safety and tolerability of ILUVIEN was monitored over 12 months.

Other adverse events

Measure	Laser n=6 participants at risk laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	Laser and Anti-VEGF n=10 participants at risk laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
Eye disorders Intra-ocular pressure (30 mmHg)	16.7% 1/6 • Number of events 1 • The safety and tolerability of ILUVIEN was monitored over 12 months.	0.00% 0/10 • The safety and tolerability of ILUVIEN was monitored over 12 months.
General disorders Dislocated Shoulder	16.7% 1/6 • Number of events 1 • The safety and tolerability of ILUVIEN was monitored over 12 months.	0.00% 0/10 • The safety and tolerability of ILUVIEN was monitored over 12 months.
Eye disorders Intra-ocular pressure (25mmHG)	0.00% 0/6 • The safety and tolerability of ILUVIEN was monitored over 12 months.	20.0% 2/10 • Number of events 2 • The safety and tolerability of ILUVIEN was monitored over 12 months.
Eye disorders Intra-ocular pressure (28mmHg)	0.00% 0/6 • The safety and tolerability of ILUVIEN was monitored over 12 months.	10.0% 1/10 • Number of events 1 • The safety and tolerability of ILUVIEN was monitored over 12 months.

Additional Information

Professor Pascale Massin

Hopital Lariboisiere

Phone: 0149 95 24 74

Email: pascale.massin@lrb.aphp.FR

Results disclosure agreements

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

Restriction type: LTE60