Diabetic Macular EdemaPhase 2EDRMTNCT03608839
Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
A Phase 2 study testing Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml, Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml and Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml in people with Diabetic Macular Edema, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml, Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml and Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2016to 5 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Diabetic Macular Edema
- Being tested
- 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
- Keywords
- Diabetic macular edema, Intravitreal dexamethasone solution, Short term treament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 mlDrug
Also called 0,01 ml intravitreous dexamethasone solution
0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 mlDrug
Also called 0,03 ml intravitreous dexamethasone solution
0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 mlDrug
Also called 0,05 ml intravitreous dexamethasone solution
0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
| Study group | Role | What they receive |
|---|---|---|
| 0,01ml dexamethasone solution | Experimental | One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. Receives: Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml |
| 0,03 ml dexamethasone solution | Experimental | One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. Receives: Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml |
| 0,05 ml dexamethasone solution | Experimental | One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. Receives: Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Thickness at 3 Days After Intravitreous Dexamethasone
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm
Measured: Three days after intravitreous dexamethasone
Secondary outcomes (5)
Macular Thickness at 28 Days After Intravitreous Dexamethasone
Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm
Measured: 28 days after intravitreous dexamethasone
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
Measured: 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
Measured: 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
Measured: 3 days after intravitreous dexamethasone
Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg
Measured: 28 days after intravitreous dexamethasone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 May 2016
- Primary completion20 Dec 2017
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
- Investigators
- Rodrigo PC Lira, MD, Study chair, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608839
- Sponsor's protocol ID
- 003
- Acronym
- EDRMT
- Status last verified
- Oct 2019
- First submitted
- 12 Jul 2018
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29127949Diabetic 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.
PubMed 20427088Elman 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.
PubMed 21459214Tamura 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.
PubMed 15790913Wang 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.
PubMed 18670086Mitchell 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.
PubMed 21459215Nguyen 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.
PubMed 22330964Photocoagulation 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.
PubMed 2866759Bandello 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.
PubMed 20703045Kempen 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.
PubMed 15078674Fonseca 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.
PubMed 31496644
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03608839
- Acronym / sponsor ID
- EDRMT / 003
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, Intravitreal dexamethasone solution, Short term treament
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0,01ml dexamethasone solution | Experimental | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 mlOne intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. |
| 0,03 ml dexamethasone solution | Experimental | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 mlOne intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. |
| 0,05 ml dexamethasone solution | Experimental | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 mlOne intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 mlAlso: 0,01 ml intravitreous dexamethasone solution0,01 ml intravitreous dexamethasone solution 4mg/ml injection. | Drug | 0,01ml dexamethasone solution |
| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 mlAlso: 0,03 ml intravitreous dexamethasone solution0,03 ml intravitreous dexamethasone solution 4mg/ml injection. | Drug | 0,03 ml dexamethasone solution |
| Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 mlAlso: 0,05 ml intravitreous dexamethasone solution0,05 ml intravitreous dexamethasone solution 4mg/ml injection. | Drug | 0,05 ml dexamethasone solution |
Primary outcome
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
5 secondary outcomes
Macular Thickness at 28 Days After Intravitreous Dexamethasone
Time frame: 28 days after intravitreous dexamethasone
Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone
Time frame: Three days after intravitreous dexamethasone
Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone
Time frame: 28 days after intravitreous dexamethasone
Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone
Time frame: 3 days after intravitreous dexamethasone
Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
Time frame: 28 days after intravitreous dexamethasone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29127949Maturi 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.
- Background: PubMed 20427088Diabetic 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.
- Background: PubMed 21459214Elman 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.
- Background: PubMed 15790913Tamura 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.
- Background: PubMed 18670086Wang 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.
- Background: PubMed 21459215Mitchell 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.
- Background: PubMed 22330964Nguyen 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.
- Background: PubMed 2866759Photocoagulation 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.
- Background: PubMed 20703045Bandello 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.
- Background: PubMed 15078674Kempen 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.
- Derived from this study: PubMed 31496644Fonseca 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.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo PC Lira, MD study chair
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml, Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml and Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml in people with Diabetic Macular Edema, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular Thickness at 3 Days After Intravitreous Dexamethasone (time frame: Three days after intravitreous dexamethasone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608839, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.