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

50 subjects receiving two DiVFuSS softgels per day

50 subjects receiving 4 DiVFuss softgels per day

Center-involved Diabetic Macular Edema (CI-DME)

The adjunctive nutritional supplement will be the multi-component formula used in the Diabetes Visual Function Supplement Study (Western IRB number 1129944 Olympia, WA), containing the macular carotenoids lutein and zeaxanthin, as well as antioxidants (vitamins B1, B12, C, D, E, lipoic acid, coenzyme Q10, resveratrol), omega3 fatty acids (EPA/DHA) and botanical extracts (Pycnogenol™ [patented extract of French maritime pine bark, Pinus pinaster], grape seed and green tea extracts, curcumin).

Diabetes Visual Function Study (DiVFuSS) softgels

Placebo containing canola oil, 2 softgels per day

canola oil placebo softgels, 2 per day

Sound Retina

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Best-corrected visual acuity at entry and conclusion of study

Change in macular subfield thicknesses from baseline to study conclusion

The number of intravitreal anti-VEGDF injections required for treatment of center-involved diabetic macular edema

The number of subjects in each arm requiring adjunctive laser photocoagulation or intravitreal steroids for treatment of CI-DME

ZeaVision, LLC

This will be an investigator initiated, single-clinic/two location, double-blinded prospective study of 150 adult subjects with newly diagnosed CI-DME receiving anti-VEGF injections, with add-on laser and/or steroid as required on follow-up examination (Standard Treatment) versus standard treatment plus adjunctive DiVFuSS supplementation in one of two doses (2 softgels per day - Supplement Treatment Group 1; and 4 softgels per day - Supplement Treatment Group 2). Subjects will be identified and enrolled with informed consent from two retinal specialty practice sites in Washington State (Sound Retina; Tacoma, WA and Olympia, WA). Subjects will be randomized to Standard Treatment; Supplement Treatment Group 1, or Supplement Treatment Group 2.

After enrollment by the study Primary Investigator, a single retinal specialist from each site, masked to subjects' supplement status, will deliver all treatments per his/her usual protocol for treatment of CI-DME based on individual examination findings. Supplements and identically-appearing placebo will be provided by ZeaVision, LLC of Chesterfield, MO.

Combination treatment: Participants will receive intravitreal Eylea (AFL, 2.0 mg) injection and OZURDEX implant (0.7 mg) injection within 0 to 8 days of each other.

Monotherapy treatment: Participants will receive OZURDEX implant (0.7 mg) injection.

Diabetic Macular Edema

OZURDEX® (DEX implant, 0.7 mg) is a micro-ionized and non-preserved dexamethasone within a cylindrically-shaped 0.45 mm diameter x 6.5 mm length biodegradable Poly D, L-lactate-co-glycolic acid pellet allowing for sustained delivery dexamethasone into the vitreous cavity and retina following intravitreal injection. Health Canada has granted approval for use of DEX implant in the treatment of ME following central retinal vein occlusion, non-infectious uveitis affecting the posterior segment and pseudophakic DME in adult patients. (OZURDEX® Canadian Product Monograph, April 14, 2015). DEX implant will be provided as investigational treatment by Allergan Inc., Markham, ON, Canada.

OZURDEX

EYLEA® (AFL 2.0 mg intravitreal injections) is an anti-VEGF treatment. AFL (2.0 mg) has received approval from Health Canada for the treatment of DME. Health Canada has also granted approval for AFL (2.0 mg) in the treatment of age-related macular degeneration, and ME secondary to retinal vein occlusion.

Eylea

Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema

Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema (COLLIDE)

Foveal central subfield (FCS) thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid.

Analyzing whether or not retreatment with the assigned intervention is required and how often in each group, comparatively

Looking for proliferative diabetic retinopathy comparatively in each group

Pradeepa Yoganathan

Ophthalmologist

St. Michael's Hospital, Toronto

Eligible participants will be randomized in a 1:1 manner to one of the following groups:
Combination treatment (Group A): 50 participants will receive an intravitreal AFL (2.0 mg) injection and DEX implant (0.7 mg) injection within 0 to 8 days of each other.
Monotherapy treatment (Group B): 50 participants will receive DEX implant (0.7 mg) injection.

2mg intravitreal aflibercept (Eylea) injection at baseline, 1M, 2M, 3M, 4M, and 5M

Diabetic Retinopathy

Six number of injections at baseline, 1M, 2M, 3M, 4M, and 5M

Intravitreal Aflibercept injection

Asan medical center

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Patients With Diabetic Retinopathy

Mean changes (%) of retinal nonperfusion (Ischemic index) from baseline

Number of patients who receive rescue treatment due to PDR and time to rescue treatment due to PDR

Number of patients who receive rescue treatment due to DME and time to rescue treatment due to DME

- Visual acuity parameters: Mean changes of BCVA from baseline at every 3 month visit The proportion of subjects with gaining / losing ≥ 15letters or more in BCVA

- Optical coherence tomography (OCT) parameters: Mean changes of Central Retinal Thickness (CRT) from baseline at every 3 month visit Mean changes of Central Retinal Volume from baseline at every 3 month visit Mean change subfoveal choroidal thickness (SFChT) from baseline at every 3 month visit

- Fluorescein angiography (FA) parameters: Baselinenonperfusion area(Ischemic index) at posterior and peripheral retina Baseline degree of vascular leakage at posterior and peripheral retina

leukostasis/edema

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy

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