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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00344968
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 years with diabetic macular edema
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of 19-68 letters
* Retinal thickness \> 250 micron by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion Criteria:
* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00344968
Study Brief:
Protocol Section:
NCT00344968