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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT02651168
Eligibility Criteria:
Inclusion Criteria
* Male or female aged 18 years or above
* Presence of Non Proliferative Diabetic Retinopathy (NPDR)
* Prior treatment with ≥ 6 intravitreal ranibizumab injections but no treatment in the last 4 weeks and less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline and less than 10% reduction in macular volume with Snellan Acuity 20/40 to 20/400
* Patients with DME with central macular thickness of 310μm or more on SD-OCT (cirrus)
* Subjects with Type I or II diabetes mellitis
* Willing and able to provide informed consent for participation in the study
Exclusion Criteria
* Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months
* Uncontrolled glaucoma
* History of intraocular surgery within 3 months in the study eye
* History of vitrectomy surgery
* Laser treatment within 3 months of study eye
* Vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye
* Prior intravitreal injection within the past 6 months
* Known allergy to the study drug or fluorescein
* History of stroke or AMI within 6 months of enrolment
* Patients receiving dialysis for renal failure
* Patients currently on systemic immunosuppression
* Patients on two or more class of medication for glaucoma in study eye
* Patients with tuberculosis
* Patients who are pregnant.
* Unwilling or unable to follow or comply with all study related procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02651168
Study Brief:
Protocol Section:
NCT02651168