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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0,01ml dexamethasone solution | Experimental | One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. |
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| 0,03 ml dexamethasone solution | Experimental | One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. |
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| 0,05 ml dexamethasone solution | Experimental | One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml | Drug | 0,01 ml intravitreous dexamethasone solution 4mg/ml injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular Thickness at 3 Days After Intravitreous Dexamethasone | Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm | Three days after intravitreous dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Macular Thickness at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo PC Lira, MD | University of Campinas, Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of Campinas | Campinas | São Paulo | 13083887 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29127949 | Background | 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. | |
| 20427088 |
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Informed written consent was obtained from all patients, and approved by the ethics committee of the Clinical Hospital of the State University of Campinas
Data from DME diagnosed volunteers was collected and analyzed at the Department of Ophthalmology, State University of Campinas (UNICAMP), Brazil between May 2016 and December 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 0,01ml Dexamethasone Solution | One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection. |
| FG001 | 0,03 ml Dexamethasone Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2019 |
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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.
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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.
| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml | Drug | 0,03 ml intravitreous dexamethasone solution 4mg/ml injection. |
|
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| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml | Drug | 0,05 ml intravitreous dexamethasone solution 4mg/ml injection. |
|
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Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart |
| Three days after intravitreous dexamethasone |
| Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone | Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart | 28 days after intravitreous dexamethasone |
| Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone | Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg | 3 days after intravitreous dexamethasone |
| Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone | Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg | 28 days after intravitreous dexamethasone |
| Background |
| 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. |
| 21459214 | Background | 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. |
| 15790913 | Background | 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. |
| 18670086 | Background | 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. |
| 21459215 | Background | 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. |
| 22330964 | Background | 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. |
| 2866759 | Background | 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. |
| 20703045 | Background | 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. |
| 15078674 | Background | 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. |
| 31496644 | Derived | 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. |
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection. |
| FG002 | 0,05 ml Dexamethasone Solution | One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0,01ml Dexamethasone Solution | One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection. |
| BG001 | 0,03 ml Dexamethasone Solution | One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection. |
| BG002 | 0,05 ml Dexamethasone Solution | One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Eye (Right) | Count of Participants | Participants |
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| Epirretinal membrane | Count of Participants | Participants |
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| Subretinal fluid | Count of Participants | Participants |
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| Microaneurysms in foveal region | Count of Participants | Participants |
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| Posterior vitreous detachment | Count of Participants | Participants |
| ||||||||||||||||
| Central macular thickness | Mean | Standard Deviation | µm |
| |||||||||||||||
| Best corrected visual acuity | Mean | Standard Deviation | ETDRS Letters |
| |||||||||||||||
| Intraocular pressure | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Macular Thickness at 3 Days After Intravitreous Dexamethasone | Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm | Macular thickness at 3 days after intravitreous dexamethasone | Posted | Mean | Standard Deviation | µm | Three days after intravitreous dexamethasone |
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| Secondary | Macular Thickness at 28 Days After Intravitreous Dexamethasone | Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm | Posted | Mean | Standard Deviation | µm | 28 days after intravitreous dexamethasone |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone | Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart | Posted | Mean | Standard Deviation | ETDRS Letters | Three days after intravitreous dexamethasone |
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| Secondary | Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone | Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart | Posted | Mean | Standard Deviation | ETDRS letters | 28 days after intravitreous dexamethasone |
|
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| Secondary | Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone | Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg | Posted | Mean | Standard Deviation | mmHg | 3 days after intravitreous dexamethasone |
|
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| Secondary | Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone | Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg | Posted | Mean | Standard Deviation | mmHg | 28 days after intravitreous dexamethasone |
|
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Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0,01ml Dexamethasone Solution | One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection. | 0 | 0 | 0 | 9 | 0 | 9 |
| EG001 | 0,03 ml Dexamethasone Solution | One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection. | 0 | 0 | 0 | 9 | 0 | 9 |
| EG002 | 0,05 ml Dexamethasone Solution | One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection. | 0 | 0 | 0 | 9 | 0 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | Systematic Assessment | Incidence of endophthalmitis after intravitreous dexamethasone solution |
| |
| Retinal detachment | Eye disorders | Systematic Assessment | Incidence of retinal detachment after intravitreous dexamethasone solution |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure elevation (IOP) > 5 mmHg from baseline | Eye disorders | Systematic Assessment | Intraocular pressure elevation > 5 mmHg from baseline or that required anti hypertensive ocular medication |
|
The primary limitation of this study was the small number of participants, likely due to the strict inclusion criteria selected.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rodrigo Pessoa Cavalcanti Lira | State University of Campinas (UNICAMP) | 551935217396 | 7396 | alayf@hotmail.com |
| Oct 5, 2019 |
| Prot_SAP_000.pdf |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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