Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

NCT ID: NCT05847088

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-04-04

Brief Summary

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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

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Intravitreal 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.

Intervention Type DRUG

Other Intervention Names

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Ozurdex

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dar El Oyoun Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wael Ahmed Ewais

Associate professor of Ophthalmology Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr alainy faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-21-2023

Identifier Type: -

Identifier Source: org_study_id

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