A Non-Randomized, Open-Label, Single Center Phase 4 Study... | NCT02472366

NCT02472366

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laser	Other	laser with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN
laser and anti-VEGF	Other	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN

Name	Type	Description	Arm Group Labels	Other Names
ILUVIEN	Drug		laser laser and anti-VEGF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Best Corrected Visual Acuity From Baseline	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.	Change from Baseline to 12 months post ILUVIEN administration

Secondary Outcomes

Measure	Description	Time Frame
Changes in Intraocular Pressure (IOP)		Change from Baseline to 12 months post ILUVIEN administration
Changes in Central Subfield Thickness		Change from Baseline to 12 months post ILUVIEN administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.

Exclusion Criteria:

IOP >21 mmHg at screening in the study eye.
Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
Patients that have vitreomacular traction in DME and opaque media in the study eye.
Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
Pregnant or breastfeeding.
Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.
Patients with contraindications according to the current SPC:
1. The presence of pre-existing glaucoma.
2. Active or suspected ocular or periocular infection.
3. The patient is hypersensitive to the active agent or to one of the excipients.

Contacts/Locations Module

No data available

No data is available for this block.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
FG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

FG0006 subjects6 subjects receiving ILUVIEN, 7 eyes receiving ILUVIEN

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
BG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG00110 BG00216

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0003.5± 7.40 OG0010.9± 15.79

Secondary

Changes in Intraocular Pressure (IOP)

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

Posted

Mean

Standard Deviation

mmHg

Change from Baseline to 12 months post ILUVIEN administration

Eyes

Participants

ID	Title	Description
OG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
OG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN

Units	Counts
Participants	OG000

Secondary

Changes in Central Subfield Thickness

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

Posted

Mean

Standard Deviation

microns

Change from Baseline to 12 months post ILUVIEN administration

Eyes

Participants

ID	Title	Description
OG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
OG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN

Units	Counts
Participants	OG000

Secondary

Changes in Macular Volume

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

Posted

Mean

Standard Deviation

mm^3

Change from Baseline to 12 months post ILUVIEN administration

Eyes

Participants

ID	Title	Description
OG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
OG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN

Units	Counts
Participants	OG000

Post-Hoc

Change in Best Corrected Visual Acuity From Baseline

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.

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

Posted

Mean

Standard Deviation

Best Corrected VA Letter Score

Change from Baseline to 12 months post ILUVIEN administration

Eyes

Participants

ID	Title	Description
OG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN
OG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Laser	laser with or without prior history of intraocular corticosteroid therapy ILUVIEN			0	6	2	6
EG001	Laser and Anti-VEGF	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN			2	10	3	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected10 at risk
Cataract Surgery	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected10 at risk
Vitrectomy	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intra-ocular pressure (30 mmHg)	Eye disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected6 at risk EG0010 events0 affected10 at risk
Dislocated Shoulder	General disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected6 at risk EG0010 events0 affected10 at risk
Intra-ocular pressure (25mmHG)	Eye disorders	MedDRA 15.1	Systematic Assessment	1 event occurred in the fellow eye	EG0000 events0 affected6 at risk EG0012 events2 affected10 at risk
Intra-ocular pressure (28mmHg)	Eye disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected6 at risk EG0011 events1 affected10 at risk

Title	Organization	Phone	Extension	Email
Professor Pascale Massin	Hopital Lariboisiere	0149 95 24 74		pascale.massin@lrb.aphp.FR

ID	Term
D005446	Fluocinolone Acetonide

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated