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Completed

NCT Number: NCT05847088

Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:

Drug

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

Other names: Ozurdex

Primary outcomes

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

    Time frame: between baseline and 6 months

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

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

    Time frame: between baseline and 6 months

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

Secondary outcomes

  1. Number of DEX injections

    Time frame: between baseline and 6 months

    Number of DEX injections

  2. Shift to anti-VEGF during follow-up

    Time frame: between baseline and 6 months

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

  3. Duration of follow-up ( months)

    Time frame: between baseline and 6 months

    Duration of follow-up ( months)

  4. CMT change > 100 u

    Time frame: between baseline and 6 months

    CMT change > 100 u (yes / No)

  5. CMT change > 200 u

    Time frame: between baseline and 6 months

    CMT change > 200 u (yes / No)

  6. BCVA change >= 2 lines

    Time frame: between baseline and 6 months

    BCVA change >= 2 lines (yes / No)

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

    Time frame: between baseline and 6 months

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

Sponsors and collaborators

Lead sponsor

Dar El Oyoun Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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