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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT00295828
Eligibility Criteria:
Inclusion criteria:
1. Male or female, at least 18 years of age
2. Diabetic retinopathy with iris neovascularization
3. Visual acuity must be light perception or better in the study eye
4. Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
5. Written informed consent has been obtained
6. Written authorization for use and release of health and research study information has been obtained
Exclusion criteria:
1. Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
2. No light perception in the study eye.
3. Inadequate view of retina for PRP/angiography
4. Anterior chamber intraocular lens implant
5. PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
6. Previous or current Macugen use
7. Any active ocular infection
8. Any conditions which precludes patients ability to comply with study requirements including completion of the study
9. Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
11. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00295828
Study Brief:
Protocol Section:
NCT00295828