A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients (RESPOND)

A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: IlUVIEN

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-548
    • Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
  • Lisboa, Portugal, 1050-085
    • Instituto de Retina de Lisboa
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao
  • Vila Franca de Xira, Portugal, 2600-009
    • Hospital Vila Franca Xira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Chronic DME patients considered insufficiently responsive to available therapies (laser, anti-VEGF) with or without intravitreal corticosteroid therapy.

Inclusion Criteria:

• 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:

  1. 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;
  2. Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
  3. If in the Investigator's opinion a further improvement is possible.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ILUVIEN 190 ug intravitreal implant; 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; 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.; Other Names: Fluocinolone Acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Association for Innovation and Biomedical Research on Light and Image

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pilot study; Chronic Diabetic Macular Edema; Iluvien; Intra-vitreal injections
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluocinolone Acetonide
• Other Study ID Numbers: 4C-2014-06