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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

PROACTIVEDME Trial Summary

This study is evaluating whether a combination of nutritional supplements may help improve vision in individuals with diabetic macular edema.

Eligible Conditions
  • Diabetic Macular Edema

PROACTIVEDME Trial Eligibility Criteria

Inclusion Criteria

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

PROACTIVEDME Trial 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

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

PROACTIVEDME 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

Find a Location

Who is running the clinical trial?

Sound RetinaOTHER
ZeaVision, LLCLead Sponsor
4 Previous Clinical Trials
367 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
divfussJournal
The Diabetes Visual Function Supplement Study (<i>divfuss</i>)
Chous, A Paul, Stuart P Richer, Jeffry D Gerson, and Renu A Kowluru. 2015. “The Diabetes Visual Function Supplement Study (divfuss)”. British Journal of Ophthalmology. BMJ. doi:10.1136/bjophthalmol-2014-306534.
clinicaltrials.govStudy
Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
2019. "Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03866005.
All > Macular Edema
~27 spots leftby May 2025
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