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• Conditions: diabetic macular edema; MedDRA version: 14.1Level: PTClassification code 10025409Term: Macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2004-004997-10-IT
• Lead Sponsor: ALLERGAN Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-06
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Male or female, at least 18 years of age 2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: - Current regular use of insulin for the treatment of diabetes - Current regular use of oral hypoglycemic agent(s)for the treatment of diabetes - Diabetes as defined by American Diabetes Association (ADA) guidelines: `? Symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) plus plasma glucose concentration at any time of the day regardless of time since last meal ¥ 200 mg/dl (11.1 mmol/l) or `? Eight-hour fasting plasma glucose ¥ 126 mg/dl (7.0 mmol/l) or `? Two-hour postload (75 g) glucose ¥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test 3. Diabetic macular edema in the study eye defined as clinically observable macular edema involving the center of the macula (fovea) associated with diabetic retinopathy, with any of the following characteristics: a) Prior medical therapy for diabetic macular edema b) Prior macular laser(s) for diabetic macular edema with the most recent laser at least 3 months prior to Baseline/ Qualification where, in the opinion of the investigator, the patient will be able to improve 15 or more letters in BCVA from baseline with the resolution of the macular edema despite the presence of macular laser scars c) In the investigator`s opinion the patient would not benefit from macular laser treatment d) The patient refuses laser treatment 4. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and 68 letters (approximately 20/50 Snellen equivalent) in the study eye measured by the ETDRS method at qualification/baseline 5. Retinal thickness of ¥ 300 µm by OCT in the 1mm central macular subfield of the study eye at qualification/baseline as determined by the investigator 6. Patients who have received intravitreal triamcinolone acetonide must satisfy the following: `? The intended dose for each injection was 4 mg or less `? The most recent dose was at least 6 months prior to qualification/baseline visit `? No treatment-related adverse event was seen that, in the opinion of the investigator, has the potential to worsen or reoccur with study treatment 7. Female patients of childbearing potential must have a negative urine pregnancy test at the randomization (day 0) visit 8. Written informed consent has been obtained 9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 10. Written Data Protection Consent (European sites only) has been obtained 11. Written documentation 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 704
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 351

Exclusion Criteria

1. Uncontrolled systemic disease or current immunosuppressive disease (e.g., HIV+, AIDS) 2. Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification/baseline visit 3. Blood HbA1c level greater than 10% at the qualification/baseline visit 4. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification/baseline visit 5. Adjusted glomerular filtration rate (GFR) less than 50 mL/min, based on the Modified Diet in Renal Disease (MDRD) formula adjusted for body surface area, at the qualification/baseline visit 6. Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy) 7. Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid macular edema or any other condition in the study eye which could be contributing to macular edema 8. Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular edema, or is severe enough to prevent improvement in visual acuity despite reduction in macular edema 9. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: 1) a ¥ 10 mm Hg increase in IOP from baseline with an absolute IOP ¥ 25 mm Hg 2) required therapy with 3 or more anti-glaucoma medications 10. History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye. Patients with a history of previous angle-closure or similar conditions that have been successfully treated with either a laser or surgical peripheral iridotomy are allowed as long as the visual fields and optic nerves have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated 11. Ocular hypertension in the study eye at qualification/baseline with any of the following: 1) IOP > 23 mm Hg if taking no anti-glaucoma medications 2) IOP > 21 mm Hg if taking one anti-glaucoma medication 3) use of 2 or more anti-glaucoma medications (combination products should be considered 2 medications) Note: Anti-glaucoma medications or lack thereof must be stable for at least 4 weeks prior to qualification/baseline. 12. Aphakia or presence of anterior chamber intraocular lens in the study eye 13. Active optic disc or retinal neovascularization in the study eye at qualification/baseline 14. Active or history of choroidal neovascularization in the study eye 15. Presence of rubeosis iridis in the study eye at qualification/baseline 16. Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at qualification/baseline 17. History of herpetic infection in the study eye or adnexa 18. Presence of active or inactive toxoplasmosis in either eye at qualification/baseline Due to space resrtiction, only Exclusion Criteria 1-18 are listed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified