Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the change in macular edema and the absolute change in visual acuity following intravitreal administered injections of Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) compared with Triamcinolone (Volon A®) in patients with clinical significant diabetic macular edema.

The investigators monitor the change in macular edema measured with standard optical coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Bevacizumab; Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Signed informed consent

• Patients with type 1 or type 2 diabetes mellitus

• Patients with diabetic macular edema with center involvement

• Central macular thickness (macular edema) of at least 300 microns in the central subfield as measured by OCT

• Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/400 (Snellen equivalent) in the study eye

• Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator

• Patients without a necessity for panretinal laser photocoagulation for at least 3 months after study inclusion

• If both eyes are eligible, the one with the worse visual acuity will be selected for study treatment unless, based on medical reason, the investigator deems the other eye have got more benefit from study treatment. The other eye will be treated with Grid laser coagulation.

Exclusion Criteria:

• A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure

• History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week

Prior/Concomitant Treatment

• Macular laser photocoagulation

• Panretinal laser photocoagulation within the past 3 months

• Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye

• Previous participation in clinical trial involving anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.)

• History of submacular surgery or other surgical intervention for diabetic macular edema in the study eye Diabetic Retinopathy Characteristics

• High risk proliferative diabetic retinopathy in the study eye without complete panretinal laser photocoagulation and having a risk for intravitreal bleeding Concurrent Ocular Conditions

• Active intraocular inflammation (grade trace or above) in either eye

• Vitreomacular traction in the study eye evident by OCT

• Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularisation

• Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0

• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication)

• History of glaucoma filtration surgery, corneal transplantation in the study eye Concurrent Systemic Conditions

• History of myocardial infarction (in anamnesis or signs in ECG)

• History of congestive heart failure

• History of stroke or transient ischemic attacks

• Significant abnormalities on laboratory testing (signs on failure of kidney, liver disease)

• Premenopausal women not using adequate contraception and pregnant or nursing women

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications

• Current treatment for active systemic infection Other

• History of allergy to fluorescein, not amenable to treatment

• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded

• Inability to comply with study or follow up procedures