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Diabetic Macular EdemaNCT05847088

Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

An observational study of Diabetic Macular Edema, run by Dar El Oyoun Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:
How many people
58 participants
Where
1 siteEgypt
Study dates
15 Feb 2023to 4 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • • 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.
Show all 9Show fewer
  • Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
  • Pseudophakic eyes
  • NPDR , PRP-treated PDR

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr alainy faculty of medicine

    Cairo, 12311

Other trials in Egypt

About this study

Official title: 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.

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.

Being tested
Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:Drug

    Also called Ozurdex

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: between baseline and 6 months

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

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

    Measured: between baseline and 6 months

Secondary outcomes (7)

  1. Number of DEX injections

    Number of DEX injections

    Measured: between baseline and 6 months

  2. Shift to anti-VEGF during follow-up

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

    Measured: between baseline and 6 months

  3. Duration of follow-up ( months)

    Duration of follow-up ( months)

    Measured: between baseline and 6 months

  4. CMT change > 100 u

    CMT change > 100 u (yes / No)

    Measured: between baseline and 6 months

  5. CMT change > 200 u

    CMT change > 200 u (yes / No)

    Measured: between baseline and 6 months

  6. BCVA change >= 2 lines

    BCVA change >= 2 lines (yes / No)

    Measured: between baseline and 6 months

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

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

    Measured: between baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start15 Feb 2023
  3. Primary completion28 Mar 2023
  4. Study completion4 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847088
Sponsor's protocol ID
N-21-2023
Status last verified
Apr 2023
First submitted
5 Apr 2023
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema, run by Dar El Oyoun Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Central macular thickness (in microns) (CMT change ) (time frame: between baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05847088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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