Status:
UNKNOWN
Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
Lead Sponsor:
ZeaVision, LLC
Collaborating Sponsors:
Sound Retina
Conditions:
Center-involved Diabetic Macular Edema (CI-DME)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 di...
Detailed Description
Diabetic retinopathy (DR) remains the leading cause of blindness in Americans of working age, and the majority of people with diabetes are expected to develop retinopathy, with as many as 10% developi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03866005
Start Date
November 1 2019
End Date
November 1 2021
Last Update
July 2 2020
Active Locations (2)
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1
Sound Retina
Olympia, Washington, United States, 98506
2
Sound Retina
Tacoma, Washington, United States, 98405