Clinical trial NCT02359526: A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Chronic Diabetic Macular Edema
Iluvien
Intra-vitreal injections
Pilot study
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
timeFrame: Baseline to 12 months
measure: Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
timeFrame: Baseline to 12 months
measure: Occurrence of Adverse events, namely cataract and elevated IOP
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
city: Lisboa
country: Portugal
facility: Instituto de Retina de Lisboa
city: Porto
country: Portugal
facility: Hospital de São João
city: Vila Franca de Xira
country: Portugal
facility: Hospital Vila Franca Xira
Study officials:
References: