Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial

• Status: Completed
• Trial end date: 2018-10-05
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal de Pernambuco
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions

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.