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Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Intravitreal dexamethasone implant

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with type 1 or type 2 diabetes diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF Exclusion Criteria: uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time previous IDI any condition precluding adequate fundus visualization uncontrolled glaucoma papillary excavation ≥ 0.7

Sites / Locations

Asociacion Para Evitar la Ceguera en Mexico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal dexamethasone implant

Arm Description

All patients were included here and received one intravitreal dexamethasone implant 0.7mg

Outcomes

Primary Outcome Measures

Change in central retinal thickness

Difference among the baseline and the posterior measurements of the CRT with OCT

Secondary Outcome Measures

Change in Best Corrected Visual Acuity

Measurement of Best Corrected Visual Acuity before and after IDI

Full Information

NCT ID

NCT05736081

First Posted

February 10, 2023

Last Updated

February 20, 2023

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT05736081

Brief Title

Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Official Title

Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

February 15, 2018 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is: How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.

Detailed Description

Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravitreal dexamethasone implant

Arm Type

Experimental

Arm Description

All patients were included here and received one intravitreal dexamethasone implant 0.7mg

Intervention Type

Procedure

Intervention Name(s)

Intravitreal dexamethasone implant

Other Intervention Name(s)

Ozurdex implant

Intervention Description

Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops

Primary Outcome Measure Information:

Title

Change in central retinal thickness

Description

Difference among the baseline and the posterior measurements of the CRT with OCT

Time Frame

Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

Secondary Outcome Measure Information:

Title

Change in Best Corrected Visual Acuity

Description

Measurement of Best Corrected Visual Acuity before and after IDI

Time Frame

Prospective: from baseline to 1 month post IDI

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Gerardo García Aguirre, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México I.A.P.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociacion Para Evitar la Ceguera en Mexico

City

Mexico city

State/Province

Coyoacan

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

IPD will be available when the summary date are published

IPD Sharing Access Criteria

VIa e-mail with José Gerardo García Aguirre MD, all IPD that underlie results in a publication will be available

Citations:

PubMed Identifier

21635964

Citation

Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011 Sep;30(5):343-58. doi: 10.1016/j.preteyeres.2011.05.002. Epub 2011 May 25.

Results Reference

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PubMed Identifier

33810434

Citation

Noma H, Yasuda K, Shimura M. Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema. Int J Mol Sci. 2021 Mar 26;22(7):3427. doi: 10.3390/ijms22073427.

Results Reference

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PubMed Identifier

33946803

Citation

Wallsh JO, Gallemore RP. Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options. Cells. 2021 Apr 29;10(5):1049. doi: 10.3390/cells10051049.

Results Reference

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PubMed Identifier

26746868

Citation

Bressler SB, Ayala AR, Bressler NM, Melia M, Qin H, Ferris FL 3rd, Flaxel CJ, Friedman SM, Glassman AR, Jampol LM, Rauser ME; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment. JAMA Ophthalmol. 2016 Mar;134(3):278-85. doi: 10.1001/jamaophthalmol.2015.5346.

Results Reference

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PubMed Identifier

24907062

Citation

Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.

Results Reference

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PubMed Identifier

28195619

Citation

Khan Z, Kuriakose RK, Khan M, Chin EK, Almeida DR. Efficacy of the Intravitreal Sustained-Release Dexamethasone Implant for Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy: Meta-Analysis and Clinical Implications. Ophthalmic Surg Lasers Imaging Retina. 2017 Feb 1;48(2):160-166. doi: 10.3928/23258160-20170130-10.

Results Reference

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Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

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