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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT03056092
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of active choroidal neovascularization secondary to AMD in the study eye
* Diagnosis of macular edema secondary to RVO: central macular thickness \>310μm due to intraretinal or subretinal edema in the study eye as measured on OCT
* Diagnosis of DME with central macular thickness \>310μm in the study eye as measured on OCT in patients with diabetes mellitus types 1 or 2
Exclusion Criteria:
* Previous intravitreal drug injections in either eye within 6 months prior to study enrollment
* Visual acuity worse than counting fingers
* Patients with other macular pathologies causing structural changes to the retina
* Patients with large submacular hemorrhages or extensive fibrosis occupying the majority (\>50%) of the lesion
* Intraocular surgery in the study eye 3 months prior to study enrollment
* Previous vitreoretinal surgery in the study eye
* Previous photodynamic or macular photocoagulation therapy within the past 6 months in the study eye for patients with AMD
* Previous photocoagulation therapy within 6 months in the study eye or anticipated need for during the course of the study for patients with RVO
* Presence of active proliferative diabetic retinopathy or patients who have had pan-retinal photocoagulation within 6 months or patients where the need to pan-retinal photocoagulation is anticipated during the course of the study for patients with DME
* History of intraocular inflammation in the study eye
* Patients on systemic or topical anti-inflammatory or steroids medications
* Patients receiving dialysis for renal failure
* Known allergy to the study drug or fluorescein
* Patients who are pregnant
* Unwilling or unable to follow or comply with all study related procedures or to sign consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03056092
Study Brief:
Protocol Section:
NCT03056092