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

Condition(s) targeted: Diabetic Macular Edema

Intervention: IlUVIEN (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Association for Innovation and Biomedical Research on Light and Image

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.

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image, Coimbra 3000-548, Portugal

Instituto de Retina de Lisboa, Lisboa 1050-085, Portugal

Hospital de São João, Porto 4200-319, Portugal

Hospital Vila Franca Xira, Vila Franca de Xira 2600-009, Portugal

Starting date: October 2014
Last updated: March 18, 2015