Diabetic Macular Edema MedDRA version: 16.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Ozurdex®
Product Name: 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)(Ozurdex®)
Pharmaceutical Form: Intravitreal implant in applicator
INN or Proposed INN: Dexam
Sponsors
Allergan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age. 2. Diagnosis of diabetes mellitus (type 1 or type 2) as defined by the World Health Organization/International Diabetes Federation (Report of a WHO/IDF consultation, 2006) - Fasting plasma glucose level = 7.0 mmol/L (126 mg/dL) or - Plasma glucose = 11.1 mmol/L (200 mg/dL) 2 hours after a 75 g oral glucose load as in a glucose tolerance test. 3. Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator in the study eye with the following characteristics: - involving the center of the macula (fovea) - VA decrease attributable to macular edema 4. BCVA score = 34 and = 70 letters (approximately 20/200 to 20/40 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method in the study eye at the screening visit. 5. Study eye mean retinal thickness by spectral domain OCT in the 1 mm central macular subfield of = 300 µm with Spectralis (Heidelberg) or 275 µm with Cirrus (Zeiss) as determined by the investigator at the screening visit. 6. (Both Eyes) Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures. 7. Written informed consent has been obtained in accordance with state and country privacy requirements, where applicable. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Systemic conditions or treatments 1. History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect the interpretation of study results or render the patient at high risk from treatment complications. 2. HbA1c (glycated hemoglobin) >12% at baseline. 3. Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to baseline or anticipated change of anti-diabetic medications during the 1-year study participation. 4. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis or peritoneal dialysis at any time during the study or adjusted glomerular filtration rate < 50 mL/min. 5. Use of systemic (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) corticosteroids within 1 month prior to screening. 6. Uncontrolled systemic disease Ocular concomitant conditions/disease 7. Any current or history of ocular disease in the study eye, other than DME that in the opinion of the investigator may confound assessment of the macula or affect central vision (for example: exudative age-related macular degeneration [AMD], geographic atrophy, macular edema due to retinal vein occlusion, uveitis, angioid streaks, histoplasmosis, active or inactive cytomegalovirus, pathological myopia, retinal detachment, macular traction, macular fibrosis or scarring, macular hole, significant cataract). 8. Increased intraocular pressure (IOP = 22 mmHg) at screening or day 1, or diagnosis of glaucoma. 9. Any active ocular inflammation or ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye at the screening visit. 10. Aphakia in the study eye or break in the posterior capsule in the study eye, unless it is a small break resulted from a YAG laser posterior capsulotomy in association with prior posterior intraocular lens implantation 11. Anticipated need for ocular surgery in the study eye during the 1-year study participation. 12. Active proliferative diabetic retinopathy and/or rubeosis. 13. BCVA score < 34 letters in fellow eye. Ocular treatment 14. Laser photocoagulation to the study eye within 3 months prior to screening. 15. Use of anti-VEGF treatment in study eye within 3 months prior to screening or use of systemic anti-VEGF within 6 months prior to screening 16. Use of intravitreal triamcinolone within 6 months prior to screening. 17. Use of topical intraocular, intravitreal (except triamcinolone, see above) or periocular corticosteroids within 3 months prior to screening in the study eye or ocular conditions in the study eye that require chronic concomitant therapy with topical, local ocular or systemically administered corticosteroids. 18. History of use of DEX PS DDS within 9 months prior to screening. 19. History of cataract surgery within the 3 months prior to baseline. 20. History of vitrectomy. 21. History of incisional glaucoma surgery. 22. Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine. Compliance / administrative. 23. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception. 24. Current enrollment in an investigational drug or device study or participation in such a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether treatment with 700 µg DEX PS DDS every 5 months provides a similar treatment effect on average change of best-corrected visual acuity (BCVA) as ranibizumab administered as per its European Summary of Product Characteristics (SmPC) in patients with DME;Secondary Objective: • To evaluate the effects of 700 µg DEX PS DDS on central retinal thickness (CRT) and other anatomical changes relative to ranibizumab 0.5 mg in patients with DME. • To evaluate the effects of 700 µg DEX PS DDS on patient-reported outcomes (PROs) relative to ranibizumab 0.5 mg in patients with DME. • To evaluate the safety of 700 µg DEX PS DDS relative to ranibizumab 0.5 mg in patients with DME. • To evaluate the effect of 700 µg DEX PS DDS on BCVA average change in pseudophakic subgroup of patients relative to ranibizumab 0.5 mg in patients with DME;Primary end point(s): The average change from baseline in BCVA across all follow-up visits will be calculated for each patient.;Timepoint(s) of evaluation of this end point: At every visit - screening, randomization (Day 1), Month 1-12 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Change from baseline in the foveal thickness based on optical coherence tomography (OCT). (2) Change from baseline in total leakage area based on fluorescein angiography (FA).;Timepoint(s) of evaluation of this end point: OCT assessment at every visit (screening, randomization (Day1), Month 1-12 visits) FA assessment at screening, month 6 and month 12. | — |
Countries
Austria, Belgium, Brazil, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactAllergan Limited EU Regulatory Dept
Allergan Ltd
Outcome results
None listed