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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00846092
Eligibility Criteria:
Inclusion Criteria:
1. Age \>= 18 years Subjects \<18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
2. Diagnosis of diabetes mellitus (type 1 or type 2)
• Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
3. At least one eye meets the study eye criteria.
4. Fellow eye meets criteria.
5. Able and willing to provide informed consent.
6. Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation.
Exclusion Criteria:
7. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
8. Subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
9. Participation in an investigational trial within 30 days of NIR participation that involved treatment with any drug that has not received regulatory approval at the time of study entry.
• Note: subjects cannot receive another investigational drug while participating in the study during the first 6 months...
10. Major surgery within 28 days prior to participation or major surgery planned during the next 6 months.
• Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
11. Subject is expecting to move out of the area during the 6 months of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00846092
Study Brief:
Protocol Section:
NCT00846092