Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.

Detailed Description
-----------------
In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3 months following cataract surgery.

Official Title
-----------------
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

Conditions
-----------------
Diabetic Macular Edema, Cataract

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Ranibizumab
* Drug: Aflibercept
* Drug: Ozurdex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years of age Gender- All Race- All Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis) >250 microns central foveal thickness Able and willing to provide informed consent Exclusion Criteria: Significant renal disease A condition that in the opinion of the investigator would preclude participation Participation in another investigational trial within 30 days of randomization Application of focal macular laser within 120 days of enrollment Administration of Iluvien implant within 3 years of enrollment Administration of intravitreal triamcinolone within 3 months of enrollment Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment Known hypersensitivity to any of the investigational products Blood pressure >180/110 Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals Individual is planning on moving within 6 months of study enrollment Macular edema secondary to cause other than diabetic macular edema Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.) Evidence of ocular infections Evidence of uncontrolled glaucoma Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anti-vascular endothelial growth factor<br>Intravitreal Bevacizumab, Ranibizumab, or Aflibercept | Drug: Bevacizumab<br>* Bevacizumab<br>* Other names: Avastin;Drug: Ranibizumab<br>* Ranibizumab<br>* Other names: Lucentis;Drug: Aflibercept<br>* Aflibercept<br>* Other names: Eylea;|
| Experimental: Ozurdex<br>Intravitreal Ozurdex | Drug: Ozurdex<br>* Ozurdex<br>* Other names: Dexamethasone implant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy | Central foveal thickness will be measured in microns by spectral domain optical coherence tomography (Heidelberg) and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups | 3 months after cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy | Snellen visual acuity will be measured and converted into logMAR and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups | 3 months after cataract surgery |