Phase 2
Completed N=27
Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Source: ClinicalTrials.gov NCT03608839 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Macular Thickness at 3 Days After Intravitreous Dexamethasone — 438.44; 465.22; 368.22 µm
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Macular Thickness at 3 Days After Intravitreous Dexamethasone |
438.44; 465.22; 368.22 | — |
| SECONDARY Macular Thickness at 28 Days After Intravitreous Dexamethasone |
554.66; 617.22; 451.44 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone |
54.22; 52.33; 60.22 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone |
58.33; 50.55; 64.11 | — |
| SECONDARY Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone |
12.33; 13.11; 12.44 | — |
| SECONDARY Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone |
12.33; 12.44; 11.88 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03608839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.