Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      This is a prospective, phase II, randomized, interventional, monocentric study. Data of
      consecutive patients with DME who volunteered to participate in the research at the
      department of ophthalmology of State University of Campinas (UNICAMP) - Brazil between May
      2016 and December 2017 were analysed.

      At the screening visit, all patients underwent complete ophthalmic evaluation, including best
      corrected visual acuity (BCVA), slit-lamp biomicroscopy, applanation tonometry, fundus
      biomicroscopy, fluorescein angiography (Visucam NM/ FA Carl Zeiss; Carl Zeiss Meditec,
      California, USA), SD- OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany). Central
      macular thickness was obtained through 7 horizontal lines ( 30° x 5° area), centered on the
      fovea, with 1536 A scans per line at 240 µm intervals.

      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.
    

Intervention name(s): 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 type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): 0,01 ml intravitreous dexamethasone solution; 0,03 ml intravitreous dexamethasone solution; 0,05 ml intravitreous dexamethasone solution
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; BB 1101
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)
Primary purpose: Treatment
Keywords: Diabetic macular edema; Intravitreal dexamethasone solution; Short term treament