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

Diabetic Macular Edema research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diabetic Macular Edema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Bevacizumab (Avastin)The intravitreal injection of Bevacizumab (Avastin®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Drug:TriamcinoloneThe intravitreal injection of triamcinolone (Volon A®) is performed in the operating room under sterile conditions at baseline. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Drug:ShamPatients receiving sham intravitreal injections do not receive an actual injection of study drug. The injecting physician performing the sham injection will be unmasked to the treatment to the treatment assignment regarding active versus sham. The injecting physician will perform the same pre-injection procedures for the patients receiving bevacizumab or triamcinolone, An empty syringe without a needle will be used in the sham injection. The injecting physician will mimic an intraocular injection by making contact with the conjunctiva and applying pressure without the needle. Immediately following the sham injection, the injecting physician will perform the same post-injection procedures as those performed on patients receiving bevacizumab or triamcinolone.

Procedure:LucentisThe intravitreal injection of Ranibizumab (Lucentis®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.05ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Avastin15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

Triamciolone30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns patients will receive a sham injection. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

Lucentis15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

Study Status

Completed

Start Date: October 2007

Completed Date: July 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.

Secondary Outcome: To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.

Study sponsors, principal investigator, and references

Principal Investigator: Ursula Schmidt-Erfurth, MD

Lead Sponsor: Medical University of Vienna

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00682539

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