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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT01506895
Eligibility Criteria:
Inclusion Criteria:
* A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Confirmation of DME in the study eye by angiography
* Confirmation of retinal thickening in the study eye by study doctor
* Best corrected visual acuity score of 78-24 letters in the study eye
Exclusion Criteria:
* Additional eye disease in the study eye that could compromise study assessments
* Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
* Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
* Uncontrolled diabetes
* Certain types of liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor)
* Current severe heart failure
* Severe asthma that is poorly controlled with medication
* Previous severe allergic reaction to food, medications, drink, insect stings, etc
* If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded
* Recent participation in a study of an investigational medication
* Any other reason the investigator deems the subject should not participate in the study
* Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01506895
Study Brief:
Protocol Section:
NCT01506895