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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT05861466
Eligibility Criteria:
Inclusion Criteria:
* Patients with diabetes mellitus type II.
* Patients with visual acuity \> 0.1, able to fixate and with clear visual media.
* Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.
Exclusion Criteria:
* Age under 40 years.
* Poorly controlled diabetics (HbA1C greater than 9.0%)
* Proliferative diabetic retinopathy.
* OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
* Neovascular AMD in the study eye.
* History of glaucoma.
* Tilted disc and optic disc anomalies.
* One-eyed patients.
* Usage of systemic or topical corticosteroids.
* Patients with a history of intraocular surgery other than cataract surgery.
* Systemc diseases rather than hypertension and diabetes mellitus.
* Corneal opacities that might hinder acquisition of good quality OCT images.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT05861466
Study Brief:
Protocol Section:
NCT05861466