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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01324869
Eligibility Criteria:
Inclusion Criteria:
* Signed the Informed Consent Form and willing to comply with study procedures;
* 18 years old ≦ either gender ≦ 75 years old;
* Confirmed diagnosed with Type 1 diabetes or Type 2 diabetes based on the diabetes diagnosis criteria;
* Clinically significant DME:
* Hard exudation within 500μm of the central foveal diameter accompanied with contiguous retina thickening;
* The edema locates within 500μm of the central foveal diameter;
* Retina thickening field \> 1DD and within the 1DD central fovea.
* BCVA score of the study eyes between 78 and 19 letters, inclusively, and the BCVA score of fellow eyes ≥ 24 letters;
* Previous treatment of antidiabetic drugs within three months preceding the screening, and blood-glucose concentration is predicted to be unchanged and stable during the whole study.
Exclusion Criteria:
* Uncontrolled glaucoma in either eye;
* Currently active ocular inflammation or infection in either eye;
* Macular edema in the study eye was caused by other diseases rather than diabetes;
* Company with any other ocular conditions failing to prevent vision loss despite improving the macular edema;
* Any other ocular diseases which may cause macular edema or vision alteration during study phase;
* Retinal macular traction or macular epiretinal membrane in study eye;
* Refractive error equate or exceed 8 diopters of myopia in study eye
* Whole or regional retinal laser photocoagulation has been applied in study eye within 6 months preceding the screening;
* Previous anti-VEGF drug treatment in study eye;
* Intraocular or periocular injection of steroid drug within 6 months preceding the screening;
* Previous ophthalmologic operation within 3 months preceding the screening and/or planning to receive an ophthalmologic operation during the study.
* There is any potential for the study eye to receive the panretinal laser photocoagulation treatment during the study;
* Previous vitrectomy in study eye.
* Uncontrolled diabetes;
* Hypertensive patients with poorly controlled blood pressure;
* Uncontrolled systemic infectious diseases;
* Systemic immune diseases;
* History of allergy;
* Any uncontrolled clinical disorders;
* Pregnant or nursing women;
* Adopt one or more adequate contraception methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01324869
Study Brief:
Protocol Section:
NCT01324869