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

Diabetic Macular Edema Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359526
• Other study ID #: 4C-2014-06
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2015
• Last updated: March 9, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Portugal	Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image	Coimbra
Portugal	Instituto de Retina de Lisboa	Lisboa
Portugal	Hospital de São João	Porto
Portugal	Hospital Vila Franca Xira	Vila Franca de Xira

Sponsors (1)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in best-corrected visual acuity (BCVA) from baseline to Month-12		Baseline to 12 months
Primary	Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12		Baseline to 12 months
Primary	Occurrence of Adverse events, namely cataract and elevated IOP		12 months