Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Bevacizumab (Avastin); Triamcinolone; Sham; Lucentis
Intervention description: 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 After injecting the total volume of 0.1ml the needle is slowly withdrawn.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.; The 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 After injecting the total volume of 0.1ml the needle is slowly withdrawn.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.; Patients 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.; The 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.
Intervention MeSH terms: Triamcinolone; Bevacizumab; Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic retinopathy; macular edema; intravitreal Avastin/ Triamcinolone / Lucentis

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).
    

Eligibility 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