NCT02359526

Brief Summary

To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

February 2, 2015

Last Update Submit

March 9, 2017

Conditions

Diabetic Macular Edema

Keywords

Chronic Diabetic Macular EdemaIluvienIntra-vitreal injectionsPilot study

Outcome Measures

Primary Outcomes (3)

  • Changes in best-corrected visual acuity (BCVA) from baseline to Month-12

    Baseline to 12 months

  • Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12

    Baseline to 12 months

  • Occurrence of Adverse events, namely cataract and elevated IOP

    12 months

Study Arms (1)

ILUVIEN 190 ug intravitreal implant

EXPERIMENTAL

All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.

Drug: IlUVIEN

Interventions

IlUVIENDRUG

All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.

Also known as: Fluocinolone Acetonide
ILUVIEN 190 ug intravitreal implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years) with chronic DME;
  • Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:
  • Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT;
  • Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
  • If in the Investigator's opinion a further improvement is possible.

You may not qualify if:

  • IOP \> 21 mmHg at screening (day -14) in the study eye.
  • Historical rise in IOP \> 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
  • Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
  • Vitreomacular traction in DME and opaque media in the study eye.
  • Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
  • Pregnant or breastfeeding women.
  • Active angiographic central macular ischaemia before baseline in the study eye.
  • Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye.
  • Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Coimbra, 3000-548, Portugal

Location

Instituto de Retina de Lisboa

Lisbon, 1050-085, Portugal

Location

Hospital de São João

Porto, 4200-319, Portugal

Location

Hospital Vila Franca Xira

Vila Franca de Xira, 2600-009, Portugal

Location

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

PT(4)