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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01389505
Eligibility Criteria:
Inclusion Criteria:
* Proliferative diabetic retinopathy eyes.
* Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye.
* Patients with and without diabetic macular edema
* Type II diabetic subjects as defined by the World Health Organization
* aged ≥ 18 years.
* Women must be using effective contraception
* Ability to provide written informed consent.
* Indication of panretinal photocoagulation in both eyes
Exclusion Criteria:
* Vitreous hemorrhage or pre-retinal hemorrhage
* Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
* Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
* Cataract
* Any intraocular surgery within 6 months before trial enrollment.
* Previous vitrectomy.
Any of the following underlying systemic diseases:
History or evidence of severe cardiac disease or previous thrombus-embolic event
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01389505
Study Brief:
Protocol Section:
NCT01389505