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CompletedNCT05847088Updated May 6, 2023

Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

An observational study in Diabetic Macular Edema, sponsored by Dar El Oyoun Hospital. Completed at 1 site in Egypt. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Dar El Oyoun Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
58
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 58 is below the median of 97 across 163 observational studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Dar El Oyoun Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

    • Phakic eyes

      • Uncontrolled Glaucoma (IOP > 24 mmHg, or cup disc ratio 0.8 or more)
      • Herpetic viral infection.
      • Untreated PDR
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
58 participants (actual)
Patient registry
No

Interventions

  • DrugIntravitreal Dexamethasone Implant for refractory Diabetic macular edema:

    Intravitreal Dexamethasone implants (DEX) (0.7 mg) (Ozurdex, Allergan, Inc, Irvine, CA, USA) had been used with greater efficacy and safety in DME.

    Also known as: Ozurdex

06

What researchers measure

Primary outcomes

  1. Change in Central macular thickness (in microns) (CMT change )

    Change in Central macular thickness (in microns) (CMT change )

    Time frame: between baseline and 6 months

  2. Change in Best corrected visual acuity (BCVA change) )

    lines of Change in Best corrected visual acuity (BCVA change) )

    Time frame: between baseline and 6 months

Secondary outcomes

  1. Number of DEX injections

    Number of DEX injections

    Time frame: between baseline and 6 months

  2. Shift to anti-VEGF during follow-up

    Shift to anti-VEGF during follow-up (Yes or No)

    Time frame: between baseline and 6 months

  3. Duration of follow-up ( months)

    Duration of follow-up ( months)

    Time frame: between baseline and 6 months

  4. CMT change > 100 u

    CMT change \> 100 u (yes / No)

    Time frame: between baseline and 6 months

  5. CMT change > 200 u

    CMT change \> 200 u (yes / No)

    Time frame: between baseline and 6 months

  6. BCVA change >= 2 lines

    BCVA change \>= 2 lines (yes / No)

    Time frame: between baseline and 6 months

  7. Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD

    Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD (yes / No)

    Time frame: between baseline and 6 months

07

Study locations

1 site
  • Kasr alainy faculty of medicine
    Cairo, 12311, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05847088
Lead sponsor
Dar El Oyoun Hospital
Responsible party
Wael Ahmed Ewais (Associate professor of Ophthalmology Cairo university, Dar El Oyoun Hospital) — Principal investigator
First posted
May 6, 2023
Start date
Feb 15, 2023
Primary completion
Mar 28, 2023
Completion
Apr 4, 2023
Last update
May 6, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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