Diabetic Macular Edema, Cataract
Conditions
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.
Interventions
Sponsors
Allergan
Bay Area Retina Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy | 3 months after cataract surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy | 3 months after cataract surgery | 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 |
Countries
United States
Outcome results
None listed