Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT05847088
• Lead Sponsor: Dar El Oyoun Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2023-02-15
• Primary Completion: 2023-03-28
• Status Verified: 2023-04
• Study Completion: 2023-04-04
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Central macular thickness (in microns) (CMT change )	between baseline and 6 months	Change in Central macular thickness (in microns) (CMT change )
Change in Best corrected visual acuity (BCVA change) )	between baseline and 6 months	lines of Change in Best corrected visual acuity (BCVA change) )

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasr alainy faculty of medicine; 🇪🇬 Cairo, Egypt