Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03780361
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03780361
Study Brief:
Protocol Section:
NCT03780361