- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03608839
Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial (EDRMT)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Sao Paulo
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Campinas, Sao Paulo, Brazil, 13083887
- State University of Campinas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0,01ml dexamethasone solution
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
|
0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
Other Names:
|
Experimental: 0,03 ml dexamethasone solution
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
|
0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
Other Names:
|
Experimental: 0,05 ml dexamethasone solution
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
|
0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular Thickness at 3 Days After Intravitreous Dexamethasone
Time Frame: Three days after intravitreous dexamethasone
|
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm
|
Three days after intravitreous dexamethasone
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular Thickness at 28 Days After Intravitreous Dexamethasone
Time Frame: 28 days after intravitreous dexamethasone
|
Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm
|
28 days after intravitreous dexamethasone
|
Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone
Time Frame: Three days after intravitreous dexamethasone
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Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart
|
Three days after intravitreous dexamethasone
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Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone
Time Frame: 28 days after intravitreous dexamethasone
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Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart
|
28 days after intravitreous dexamethasone
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Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone
Time Frame: 3 days after intravitreous dexamethasone
|
Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg
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3 days after intravitreous dexamethasone
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Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
Time Frame: 28 days after intravitreous dexamethasone
|
Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg
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28 days after intravitreous dexamethasone
|
Collaborators and Investigators
Investigators
- Study Chair: Rodrigo PC Lira, MD, University of Campinas, Brazil
Publications and helpful links
General Publications
- Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.
- Diabetic Retinopathy Clinical Research Network, Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.
- Elman MJ, Bressler NM, Qin H, Beck RW, Ferris FL 3rd, Friedman SM, Glassman AR, Scott IU, Stockdale CR, Sun JK; Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):609-14. doi: 10.1016/j.ophtha.2010.12.033.
- Tamura H, Miyamoto K, Kiryu J, Miyahara S, Katsuta H, Hirose F, Musashi K, Yoshimura N. Intravitreal injection of corticosteroid attenuates leukostasis and vascular leakage in experimental diabetic retina. Invest Ophthalmol Vis Sci. 2005 Apr;46(4):1440-4. doi: 10.1167/iovs.04-0905.
- Wang K, Wang Y, Gao L, Li X, Li M, Guo J. Dexamethasone inhibits leukocyte accumulation and vascular permeability in retina of streptozotocin-induced diabetic rats via reducing vascular endothelial growth factor and intercellular adhesion molecule-1 expression. Biol Pharm Bull. 2008 Aug;31(8):1541-6. doi: 10.1248/bpb.31.1541.
- Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):615-25. doi: 10.1016/j.ophtha.2011.01.031.
- Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, Gibson A, Sy J, Rundle AC, Hopkins JJ, Rubio RG, Ehrlich JS; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801. doi: 10.1016/j.ophtha.2011.12.039. Epub 2012 Feb 11.
- Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
- Bandello F, Battaglia Parodi M, Lanzetta P, Loewenstein A, Massin P, Menchini F, Veritti D. Diabetic macular edema. Dev Ophthalmol. 2010;47:73-110. doi: 10.1159/000320075. Epub 2010 Aug 10.
- Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. doi: 10.1001/archopht.122.4.552.
- Fonseca ALA, Panetta H, Nascimento MA, Lira RPC, Arieta CEL. Effect of intravitreal dexamethasone solution on the reduction of macular thickness in pseudophakic diabetic patients in a public hospital in Brazil: a randomized clinical trial. Clin Ophthalmol. 2019 Aug 9;13:1523-1531. doi: 10.2147/OPTH.S214329. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Pharmaceutical Solutions
Other Study ID Numbers
- 003 (NuSkin International)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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