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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00815360
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
Patient related considerations:
• Patients with Type I or Type II diabetes
Disease related considerations:
* Study eye with clinically significant diabetic macular edema characterized by macular edema, peripheral nonperfusion, and absence of macular traction on clinical exam, UWFA, and OCT.
* Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and 20/320 (≥ 19 letters on ETDRS chart) Other considerations
* Patient able to complete all study visits
* Female patients must be using two forms of contraception
Exclusion Criteria:
* Pregnancy (positive pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an Intra Uterine Device, or contraceptive hormone implant or patch.
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
* Previous panretinal scatter laser photocoagulation
* Previous pars plana vitrectomy
* Visually-significant significant cataracts as primary reason for vision loss
* Uncontrolled or advanced glaucoma
* Patients on more than one anti-glaucoma agent
* Myocardial infarction or cerebrovascular accident within 6 months
* Subjects with poor glycemic control that have initiated intensive insulin treatment or plan to do so in the next 4 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00815360
Study Brief:
Protocol Section:
NCT00815360