Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Center-involved Diabetic Macular Edema (CI-DME)
In brief
This study will evaluate the effects of add-on carotenoid plus anti-oxidant nutritional supplementation to standard anti-vascular endothelial growth factor therapy for subjects with center-involved diabetic macular edema
Key facts
- Study ID
- NCT03866005
- Run by
- ZeaVision, LLC
- People needed
- 150
- Starts
- 2019-11-01
- Expected to finish
- 2021-11-01
- Last updated by the study team
- 2020-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed diabetes mellitus and treatment-naïve CI-DME requiring anti-VEGF therapy per retinal specialist's customary treatment regimen will be recruited to participate in the study. CI-DME will be defined as a central subfield thickness (CST) > 300 microns on spectral domain optical coherence tomography (SD-OCT) or CST > 250 microns with definite intra-retinal cystic fluid accumulation. Additional inclusion criteria are age > 18 years, and ability to give informed consent.
You may not qualify if…
- Age < 18 years, inability to give informed consent, evidence of proliferative diabetic retinopathy, evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity), history of previous intraocular surgery, including macular or panretinal photocoagulation (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment), pregnant and nursing women, known sensitivity to any of the supplement ingredients.
Where it is running
- Sound Retina — Olympia, Washington, United States (enrolling)
- Sound Retina — Tacoma, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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