NCT03832179CompletedPhase 4
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 5 Feb 2019
- Start date
- 15 Nov 2018
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Bay Area Retina Associates
- Diseases
- Diabetic eye disease
- NCT number
- NCT03832179
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 16
- From 15 Nov 2018 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of Iluvien implant within 3 years of enrollment
- Known hypersensitivity to any of the investigational products
Other illness
- Significant renal disease
- A condition that in the opinion of the investigator would preclude participation
- 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
- Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex
Other
- Participation in another investigational trial within 30 days of randomization
- Application of focal macular laser within 120 days 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
- 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
- Evidence of uncontrolled glaucoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.