Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema: Anatomical and Functional Outcomes of Treatment and Retreatment

We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:

Detailed Description

Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Kasr Alainy Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Retrospective Review of records of patients with Non-tractional diffuse diabetic macular edema (NTDME), for whom Ozurdex had been used , in the period between 2016 and 2022.

Description

Inclusion Criteria:

• • Age: 16 or older (Adults)

  • Sex: both
  • NTDME with CMT >300 u
  • < 10% reduction in CMT (than previous treatment)
  • < 50 u reduction in CMT (than previous treatment)
  • Worsening of BCVA > 1 line on E chart.
  • Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
  • Pseudophakic eyes
  • NPDR , PRP-treated PDR

Exclusion Criteria:

• • Phakic eyes

  • Uncontrolled Glaucoma (IOP > 24 mmHg, or cup disc ratio 0.8 or more)
  • Herpetic viral infection.
  • Untreated PDR

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central macular thickness (in microns) (CMT change )	Change in Central macular thickness (in microns) (CMT change )	between baseline and 6 months
Change in Best corrected visual acuity (BCVA change) )	lines of Change in Best corrected visual acuity (BCVA change) )	between baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of DEX injections	Number of DEX injections	between baseline and 6 months
Shift to anti-VEGF during follow-up	Shift to anti-VEGF during follow-up (Yes or No)	between baseline and 6 months
Duration of follow-up ( months)	Duration of follow-up ( months)	between baseline and 6 months
CMT change > 100 u	CMT change > 100 u (yes / No)	between baseline and 6 months
CMT change > 200 u	CMT change > 200 u (yes / No)	between baseline and 6 months
BCVA change >= 2 lines	BCVA change >= 2 lines (yes / No)	between baseline and 6 months
Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD	Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD (yes / No)	between baseline and 6 months

Collaborators and Investigators

• Sponsor: Dar El Oyoun Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: N-21-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No