This is a non-randomised, open-label which means that patients know they will receive the active medicine. No placebo will be used. The study will examine the effect and safety of Iluvien® in chronic diabetic macular edema patients. Patients would have been treated previously with other available therapies such as laser photo coagulation or a therapy called anti-VEGF or with corticosteroid therapy.

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) - RESPOND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003491-23-PT

Enrollment

Unknown

Registered

2014-10-14

Start date

2014-10-10

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diabetic Medical Edema

Interventions

Trade Name: ILUVIEN 190 microgramas implante intravítreo em apliacador. Pharmaceutical Form: Intravitreal implant in applicator INN or Proposed INN: FLUOCINOLONE ACETONIDE CAS Number: 67-73-2 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients =18 years of age, of either sex that have signed informed consent. 2. Chronic DME, defined as a history of macular edema with duration > 1 year having already received other therapy, based on investigator’s clinical evaluation and demonstrated using fundoscopic photography and SD-OCT. 3. 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: • Mean central foveal thickness (central subfield thickness) = 290um in women and = 305um in men in Zeiss Cirrus OR = 305um in women and = 320um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT; • Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME; • If in the Investigator’s opinion a further improvement is possible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: 1. IOP > 21 mmHg at screening (day -14) in the study eye. 2. Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye. 3. Use of = 2 active agents as IOP-lowering medications to control IOP at screening in the study eye. 4. Patients that have vitreomacular traction in DME and opaque media in the study eye. 5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye. 6. Pregnant or breastfeeding women. 7. Patients diagnosed with active angiographic central macular ischaemia prior to screening in the study eye. 8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the screening visit in the study eye. 9. Patients with contraindications: a. Presence of pre-existing glaucoma. b. Active or suspected ocular or periocular infection. c. The patient is hypersensitive to the active agent or to one of the excipients. 10. 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 (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices – IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect and safety of ILUVIEN in patients with chronic DME insufficiently responsive to prior available therapies with or without prior history of intraocular corticosteroid therapy.;Secondary Objective: Not applicable;Primary end point(s): - 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 ;Timepoint(s) of evaluation of this end point: Evaluation done at Months 1, 3, 6, 9 and 12.	—

Measure

Time frame

Main Objective: To assess the effect and safety of ILUVIEN in patients with chronic DME insufficiently responsive to prior available therapies with or without prior history of intraocular corticosteroid therapy.;Secondary Objective: Not applicable;Primary end point(s): - 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 ;Timepoint(s) of evaluation of this end point: Evaluation done at Months 1, 3, 6, 9 and 12.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Portugal

Contacts

Public ContactTiago Ferreira

AIBILI – Association for Innovation and Biomedical Research on Light and Image

tferreira@aibili.pt00351239480141

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026