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

NCT02472366 | Completed Phase 4 Results

• 1 other identifier: M-01-13-002
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

• Changes in Macular Volume

  Change from Baseline to 12 months post ILUVIEN administration

Study Arms (2)

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

Interventions

ILUVIEN DRUG

laser; laser and anti-VEGF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alimera Sciences: lead

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Professor Pascale Massin
• Organization: Hopital Lariboisiere

pascale.massin@lrb.aphp.FR

0149 95 24 74

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 16, 2015
• Results First Posted: September 16, 2015

Record last verified: 2015-08