Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml; Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml; Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml
Intervention description: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.; 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.; 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At the baseline study visit, patients were randomized with a 1:1:1 allocation to receive dexamethasone solution 4 mg/ml: 0,01 ml (40 µg); or 0,03 ml (120 µg); or 0,05 ml (200 µg). In follow up visits (1, 3, 7, 14, 21, 28 days after) were performed BCVA, slit-lamp biomicroscopy, applanation tonometry, fundus biomicroscopy, SD- OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany). The randomization schedule was computer generated and stored in a locked cabinet until the study ended. Both patients and the study personnel who collected BCVA, OCT data were masked to the patient study assignment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All the patients were masked. They didn't have acess to the group they belonged.
The care provider didn't know the quantity of the drug injected. The outcome assessor was masked as well.
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; Intravitreal dexamethasone solution; Short term treament

Summary:

      Purpose: To determine the impact of short-term 4mg/ml dexamethasone solution treatment in
      diabetic macular edema (DME).

      Design: Phase II, randomized, prospective, parallel, interventional study.

      Participants: Pseudophakic patients with central-involved DME.

      Methods: Twenty-seven patients with visual impairment caused by DME were randomized in a
      1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml
      intravitreous dexamethasone solutions, and followed-up over 28 days

      Outcome Measures: The primary outcome was macular thickness at three days after intravitreous
      dexamethasone. The secondary outcomes were macular thickness at 28 days after intravitreous
      dexamethasone, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at three
      and 28 days after intravitreous dexamethasone
    

Eligibility criteria:

        Inclusion Criteria:

          -  age > = 18 years;

          -  diagnosis of DM type 2;

          -  pseudophakic patients

          -  presence of clinically significant DME according to ETDRS guidelines;

          -  best correct visual acuity (BCVA) between 20/400 and 20/40;

          -  central macular thickness (CMT) >= 300 µm measured by spectral domain optical
             coherence tomography ( Spectralis® Heidelberg). If both eyes of the patient met the
             elegibility criteria, the eye with worse BCVA at baseline was designated as the study
             eye.

        Exclusion Criteria:

          -  any treatment of DME in the previous 4 months;

          -  pan retinal photocoagulation (PRP) in the previous 4 months or antecipated need of PRP
             for the next 6 months;

          -  any ophthalmologic surgery performed in the previous 4 months;

          -  history of pars plana vitrectomy;

          -  history of open-angle glaucoma or intraocular pressure elevation induced by
             corticosteroids that required anti-glaucomatous treatment or anti- hypertensive ocular
             treatment;

          -  intraocular pressure >= 21 mmHg;

          -  patients with characteristics that meet the inclusion criteria, but refused to sign
             the written general consent.