Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patients Treated With Aflibercept (FORESIGHT)

NCT03780361 | Completed Phase 4

• 1 other identifier: 20658
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of aflibercept on the change of cytokines incluing sCD14, MCP-1, IL-6, and ICAM-1 in the aqueous humor of DME patients. Additionally, changes of visual acuity (ETDRS), optical coherence tomography parameters including hyperreflective foci and thickness of macula are also investigated.

Conditions

Diabetic Macular Edema

Keywords

soluble CD14; MCP-1; IL-6; ICAM-1; cytokine; visual acuity; optical coherence tomography; macular thickness; hyperreflective foci

Outcome Measures

Primary Outcomes (1)

• Change in the level of sCD14 in the aqueous humor

  Change in the level of sCD14 in the aqueous humor measured by ELISA

  From baseline to week 20

Secondary Outcomes (4)

• Change in the levels of cytokines (MCP-1, IL-6, ICAM-1) in the aqueous humor

  From baseline to week 20

• Change in the number of hyperreflective foci (HF) on optical coherence tomography (OCT)

  From baseline to week 20

• Change in the thickeness of macula on OCT

  From baseline to week 20

• Change in mean visual acuity (ETDRS)

  From baseline to week 20

Study Arms (1)

Aflibercept injection group

EXPERIMENTAL

drug: Eylea (aflibercept) (11.12mg/0.278ml) dose: 2mg (0.05ml) usage: With topical anesthesia and intravitreal injection of aflibercpt in aseptic condition. frequency and duration: monthly intravitreal aflibercept injections.

Drug: Aflibercept Injection

Interventions

Aflibercept Injection DRUG

Total 5 times of monthly intravitreal aflibercept injections will be done.

Also known as: Eylea

Aflibercept injection group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 19 years with type 1 or 2 diabetes mellitus.
• Patients with DME secondary to diabetes mellitus involving the center of the macula (defined as the OCT center subfield) in the study eye.
• Decrease in vision determined to be primarily the result of DME in the study eye.
• BCVA ETDRS letter score of 80 to 24 (20/25 to 20/320) in the study eye.
• Retinal thickness ≥ 300 µm as assessed by OCT in the study eye.
• Willing and able to comply with clinic visits and study-related procedures.

You may not qualify if:

• Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
• History of vitreoretinal surgery in the study eye.
• Previous treatment with intraocular anti-angiogenic drugs (bevacizumab, ranibizumab etc.) or laser photocoagulation in the study eye within 90 days.
• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1.
• Invasive intraocular surgery incluing cataract surgery within 90 days of day 1.
• Yttrium-aluminium-garnet capsulotomy in the study eye within 30 days before day 1.
• Aphakia in the study eye.
• Vitreomacular traction or epiretinal membrane in the study eye evident on OCT that is thought to affect central vision.
• Active proliferative diabetic retinopathy in the study eye.
• Current iris neovascularization in the study eye.
• Evidence of infection including infectious blepharitis, keratitis, scleritis, conjunctivitis or endophthalmitis in either eye.
• Uncontrolled glaucoma in the study eye or filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye.
• Intraocular pressure ≥25 mmHg in the study eye.
• Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥ -8 diopters.
• Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including uveitis, retinal vascular occlusion, retinal detachment, macular hole, significanlty large hard exudate at macula, atrophy of retinal pigment epithelium, submacular scar, macular isdhemia, or choroidal neovascularization).

Sponsors & Collaborators

• Hyewon Chung: lead
• Bayer: collaborator

Study Sites (1)

Konkuk medical center

Seoul, 05030, South Korea

Location

Related Publications (1)

• Lee H, Jang H, Choi YA, Kim HC, Chung H. Association Between Soluble CD14 in the Aqueous Humor and Hyperreflective Foci on Optical Coherence Tomography in Patients With Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):715-721. doi: 10.1167/iovs.17-23042.

  PMID: 29392317 BACKGROUND

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: May 17, 2019
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)