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Experimental Arm - 2 DiVFuSS formula softgel capsules for Diabetic Macular Edema (PROACTIVEDME Trial)

N/A
Waitlist Available
Research Sponsored by ZeaVision, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

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 diabetic macular edema

Eligible Conditions
  • Diabetic Macular Edema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best-corrected visual acuity
Required number of anti-VEGF injections
SD-OCT macular subfield thicknesses
Secondary study objectives
Need for adjunctive laser photocoagulation and/or use of intravitreal steroids

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Arm - 4 DiVFuSS formula softgel capsulesExperimental Treatment1 Intervention
50 subjects receiving 4 DiVFuss softgels per day
Group II: Experimental Arm - 2 DiVFuSS formula softgel capsulesExperimental Treatment1 Intervention
50 subjects receiving two DiVFuSS softgels per day
Group III: Placebo Arm - Standard TreatmentPlacebo Group1 Intervention
50 subjects with center-involved diabetic macular edema (CI-DME) and scheduled for treatment with intravitreal injection of anti-VEGF agents will receive softgel placebo containing canola oil, 2 capsules per day during the study duration

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Who is running the clinical trial?

Sound RetinaOTHER
ZeaVision, LLCLead Sponsor
4 Previous Clinical Trials
367 Total Patients Enrolled
~26 spots leftby Sep 2025
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