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

NCT05736081 | Completed Phase 4 FDA Drug

• 1 other identifier: RE-20-13
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema; Ozurdex; Dexamethasone intravitreal implant

Outcome Measures

Primary Outcomes (1)

• Change in central retinal thickness

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

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

Secondary Outcomes (1)

• Change in Best Corrected Visual Acuity

  Prospective: from baseline to 1 month post IDI

Study Arms (1)

Intravitreal dexamethasone implant

EXPERIMENTAL

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

Drug: Intravitreal dexamethasone implant

Interventions

Intravitreal dexamethasone implant DRUG

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

Also known as: Ozurdex implant

Intravitreal dexamethasone implant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
• previous IDI
• any condition precluding adequate fundus visualization
• uncontrolled glaucoma
• papillary excavation ≥ 0.7

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociacion Para Evitar la Ceguera en Mexico

Mexico City, Coyoacan, 04030, Mexico

Location

Related Publications (7)

• 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.

  PMID: 21635964 BACKGROUND

• 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.

  PMID: 33810434 BACKGROUND

• 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.

  PMID: 33946803 BACKGROUND

• 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.

  PMID: 26746868 BACKGROUND

• 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.

  PMID: 24907062 BACKGROUND

• 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.

  PMID: 28195619 BACKGROUND

• Moreno JB, Medina DB, Rosellon-Escobar MF, Garcia-Aguirre JG. Short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema. BMC Ophthalmol. 2024 Mar 11;24(1):113. doi: 10.1186/s12886-024-03341-9.

  PMID: 38462613 DERIVED

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• José Gerardo García Aguirre, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available when the summary date are published
• Access Criteria: VIa e-mail with José Gerardo García Aguirre MD, all IPD that underlie results in a publication will be available

Locations

ME (1)