A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Sponsor||Association for Innovation and Biomedical Research on Light and Image|
|Start date||October 2014|
|End date||March 2016|
|Trial size||12 participants|
|Trial identifier||NCT02359526, 4C-2014-06|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Coimbra, Portugal||Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image||no longer recruiting|
|Lisboa, Portugal||Instituto de Retina de Lisboa||no longer recruiting|
|Porto, Portugal||Hospital de São João||no longer recruiting|
|Vila Franca de Xira, Portugal||Hospital Vila Franca Xira||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
time frame: Baseline to 12 months
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
Occurrence of Adverse events, namely cataract and elevated IOP
time frame: 12 months
Male or female participants at least 18 years old.
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.
|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)|
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