Changes in inflammatory biomarkers including soluble CD14 and hyperreflective foci in diabetic macular edema patients treated with aflibercept
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0003712
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
PURPOSE. To investigate the associations between consecutive aflibercept treatment and soluble CD14 (sCD14), anatomical features including hyperreflective foci (HF), and morphologic characteristics on spectral-domain optical coherence tomography (SD-OCT) in diabetic macular edema (DME). METHODS. Current prospective study includes a total of 23 eyes of 23 patients with DME were treated with 5 consecutive monthly intravitreal injections of aflibercept. At each visit, sCD14 and VEGF levels in the aqueous humor (AH) were measured using ELISA and number of HF, central macular thickness (CMT), volumes of intraretinal fluid (IRF), and subretinal fluid (SRF) were assessed by OCT. RESULTS. One month after 5 consecutive intravitreal injections, the number of HF, CMT, and the volume of IRF and SRF all decreased significantly, with a marked increase in visual acuity measured. The level of sCD14 also decreased, however, its change was not statistically significant. When comparing the increased sCD14 group with the decreased sCD14 group after five injections, the decreased sCD14 group showed improvement in all factors, including visual acuity, whereas the increased sCD14 group only showed a significant decrease in CMT. When the group was divided into two groups according to the ranking of final visual outcome after five injections, it was observed that the level of sCD14 was lower in the group with good final visual acuity at all visits. CONCLUSIONS. This study shows that the level of sCD14 in the aqueous humor of eyes with DME is associated with the anatomical changes as well as visual outcomes after 5 consecutive injections of intravitreal aflibercept, therefore could be the new biomarker reflecting treatment response to aflibercept.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
1. Adults = 19 years with type 1 or 2 diabetes mellitus.
2. Patients with DME secondary to diabetes mellitus involving the center of the macula (defined as the OCT center subfield) in the study eye.
3. Decrease in vision determined to be primarily the result of DME in the study eye.
4. BCVA ETDRS letter score of 80 to 24 (20/25 to 20/320) in the study eye.
5. Retinal thickness = 300 µm as assessed by OCT in the study eye.
6. Willing and able to comply with clinic visits and study-related procedures.
1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
2. History of vitreoretinal surgery in the study eye.
3. Previous treatment with intraocular anti-angiogenic drugs (bevacizumab, ranibizumab etc.) or laser photocoagulation in the study eye within 90 days.
4. Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1.
5. Invasive intraocular surgery incluing cataract surgery within 90 days of day 1.
6. Yttrium-aluminium-garnet capsulotomy in the study eye within 30 days before day 1.
7. Aphakia in the study eye.
8. Vitreomacular traction or epiretinal membrane in the study eye evident on OCT that is thought to affect central vision.
9. Active proliferative diabetic retinopathy in the study eye.
10. Current iris neovascularization in the study eye.
11. Evidence of infection including infectious blepharitis, keratitis, scleritis, conjunctivitis or endophthalmitis in either eye.
12. 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.
13. Intraocular pressure =25 mmHg in the study eye.
14. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of = -8 diopters.
15. 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).
16. Only one functional eye even if that eye is otherwise eligible for the study.
17. Ocular media of insufficient quality to obtain fundus and OCT images.
18. Current treatment for a serious systemic infection.
19. Administration of systemic anti-angiogenic agents within 180 days before day 1.
20. Pregnant women, pregnancy planning during the study period, lactating
21. Severe active intraocular inflammation is observed in the eyes injected with Aflibercept
22. History of hypersensitivity to Aflibercept or excipient
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the level of sCD14 in the aqueous humor
- Secondary Outcome Measures
Name Time Method Change in the levels of cytokines (MCP-1, IL-6, ICAM-1) in the aqueous humor;Change in the number of hyperreflective foci (HF) on optical coherence tomography (OCT);Change in the thickeness of macula on OCT;Change in mean visual acuity (ETDRS)