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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

Primary Purpose

Chronic Diabetic Macular Edema

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

ILUVIEN

About this trial

This is an interventional treatment trial for Chronic Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

laser

laser and anti-VEGF

Arm Description

laser with or without prior history of intraocular corticosteroid therapy

laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Intraocular Pressure (IOP)

Changes in Central Subfield Thickness

Changes in Macular Volume

Full Information

NCT ID

NCT02472366

First Posted

June 10, 2015

Last Updated

August 14, 2015

Sponsor

Alimera Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02472366

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alimera Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

laser

Arm Type

Other

Arm Description

laser with or without prior history of intraocular corticosteroid therapy

Arm Title

laser and anti-VEGF

Arm Type

Other

Arm Description

laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy

Intervention Type

Drug

Intervention Name(s)

ILUVIEN

Primary Outcome Measure Information:

Title

Changes in Best Corrected Visual Acuity From Baseline

Description

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.

Time Frame

Change from Baseline to 12 months post ILUVIEN administration

Secondary Outcome Measure Information:

Title

Changes in Intraocular Pressure (IOP)

Time Frame

Change from Baseline to 12 months post ILUVIEN administration

Title

Changes in Central Subfield Thickness

Time Frame

Change from Baseline to 12 months post ILUVIEN administration

Title

Changes in Macular Volume

Time Frame

Change from Baseline to 12 months post ILUVIEN administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: The presence of pre-existing glaucoma. Active or suspected ocular or periocular infection. The patient is hypersensitive to the active agent or to one of the excipients.

12. IPD Sharing Statement

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