Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

Study Overview
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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.

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central macular thickness (in microns) (CMT change ) | Change in Central macular thickness (in microns) (CMT change ) | between baseline and 6 months | 
| Change in Best corrected visual acuity (BCVA change) ) | lines of Change in Best corrected visual acuity (BCVA change) ) | between baseline and 6 months | 

Secondary Outcome Measures

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