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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
IlUVIEN
Sponsored by
Association for Innovation and Biomedical Research on Light and Image
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Chronic Diabetic Macular Edema, Iluvien, Intra-vitreal injections, Pilot study

Eligibility Criteria

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

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.

Sites / Locations

  • Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
  • Instituto de Retina de Lisboa
  • Hospital de São João
  • Hospital Vila Franca Xira

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ILUVIEN 190 ug intravitreal implant

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
Occurrence of Adverse events, namely cataract and elevated IOP

Secondary Outcome Measures

Full Information

First Posted
February 2, 2015
Last Updated
March 9, 2017
Sponsor
Association for Innovation and Biomedical Research on Light and Image
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1. Study Identification

Unique Protocol Identification Number
NCT02359526
Brief Title
A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients
Acronym
RESPOND
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association for Innovation and Biomedical Research on Light and Image

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Chronic Diabetic Macular Edema, Iluvien, Intra-vitreal injections, Pilot study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILUVIEN 190 ug intravitreal implant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IlUVIEN
Other Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
Time Frame
Baseline to 12 months
Title
Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
Time Frame
Baseline to 12 months
Title
Occurrence of Adverse events, namely cataract and elevated IOP
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. 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.
Facility Information:
Facility Name
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
Instituto de Retina de Lisboa
City
Lisboa
ZIP/Postal Code
1050-085
Country
Portugal
Facility Name
Hospital de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital Vila Franca Xira
City
Vila Franca de Xira
ZIP/Postal Code
2600-009
Country
Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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