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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT02151695
Eligibility Criteria:
Inclusion Criteria:
* Patients with diabetes mellitus type 1 or type 2 complicated by PDR
* Male or female over 18 years
* HbA1c \<11.6% at study entry
* Systolic blood pressure \<160 mmHg and diastolic blood pressure \<105 mmHg at study entry
* Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
Exclusion Criteria:
* Hypersensitivity to aflibercept or to any of the excipients
* History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
* PDR associated with tractional retinal detachment in the eye studied
* PDR associated with fibrovascular proliferation in the eye studied
* Florid diabetic retinopathy
* Eye infection or periocular active or suspected
* Unbalanced glaucoma in the eye studied
* Other eye disease in the eye studied
* Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02151695
Study Brief:
Protocol Section:
NCT02151695