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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359526
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: IlUVIEN Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: Fluocinolone Acetonide




Primary Outcome Measures :
  1. Changes in best-corrected visual acuity (BCVA) from baseline to Month-12 [ Time Frame: Baseline to 12 months ]
  2. 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 ]
  3. Occurrence of Adverse events, namely cataract and elevated IOP [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359526


Locations
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Portugal
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Portugal, 3000-548
Instituto de Retina de Lisboa
Lisboa, Portugal, 1050-085
Hospital de São João
Porto, Portugal, 4200-319
Hospital Vila Franca Xira
Vila Franca de Xira, Portugal, 2600-009
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
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Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT02359526    
Other Study ID Numbers: 4C-2014-06
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
Chronic Diabetic Macular Edema
Iluvien
Intra-vitreal injections
Pilot study
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs