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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01218750
Eligibility Criteria:
Inclusion Criteria:
1. diagnosis of DDME on clinical exam, definite retinal thickening involving the center of the macula, confirmed by fluorescein angiography, with or without PVD,
2. BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,5 or better in log MAR units (\>=10 ETRDS letter),
3. mean central macular thickness greater than 250 μm on optic coherence tomography (OCT),
4. presence of vitreomacular traction or a thickened and taut posterior hyaloid or presence of an epimacular membrane.
Exclusion Criteria:
1. significant macular ischemia defined as enlarged perifoveal capillary loss (\>1000 µm) by fluorescein angiography,
2. the focal macular edema due to focal leakage from microaneurysm,
3. ophthalmic disorders associated with macular edema, such as uveitis, branch or central retinal vein occlusion and pseudophakic cystoid macular edema,
4. vitreous hemorrhage or tractional retinal detachment secondary to diabetic retinopathy,
5. an ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, dense subfoveal hard exudates),
6. history of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3 months prior to enrollment,
7. history of any intraocular surgery within prior 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01218750
Study Brief:
Protocol Section:
NCT01218750