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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT06662994
Eligibility Criteria:
Inclusion Criteria:
* A patient must meet the following criteria at both the screening and randomization visits (except where indicated) to be eligible for inclusion in the study:
1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus
2. DME with central involvement in the study eye with CRT ≥320 μm on Spectralis.
3. BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 84 to 20 (approximate Snellen equivalent of 20/25 to 20/400) in the study eye with decreased vision determined to be primarily the result of DME
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide informed consent signed by study patient or legally acceptable representative
6. Have a previous history of vitrectomy surgery.
Exclusion Criteria:
* A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study:
1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye
2. Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time
3. IOP ≥28 mmHg in the study eye
4. History of glaucoma filtration surgery in the past
5. Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit.
6. Any intraocular inflammation/infection in either eye within 6 weeks (42 days) of the screening visit.
7. History of idiopathic or autoimmune uveitis in the study eye
8. Vitreomacular traction or epiretinal membrane in the study eye evident on biomicroscopy or OCT that is thought to affect central vision
9. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
10. History of corneal transplant or corneal dystrophy in study eye
11. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
12. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates
13. Inability to obtain photographs, FA, or SD-OCT in the study eye, eg, due to media opacity, allergy to fluorescein dye, or lack of venous access
14. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of high dose aflibercept or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
15. Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) \> 14%
16. History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) of screening visit
17. Known sensitivity to any of the compounds of the study formulation
18. Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device
19. Pregnant or breastfeeding women
20. Men or women of childbearing potential (WOCBP)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06662994
Study Brief:
Protocol Section:
NCT06662994