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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT05959304
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
2. Patients with type 1 or type 2 diabetes mellitus.
3. Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.
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Exclusion Criteria:
1. Concomitant conditions or ocular disorders in the study eye at screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
2. Patient with existing or suspected ocular or periocular infection in the study eye.
3. Patient with an existing intraocular inflammation (IOI) in the study eye.
4. Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
5. Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
6. Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye.
7. Active proliferative diabetic retinopathy in the study eye as per Investigator.
8. Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.
9. Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye.
10. Pregnant or nursing (lactating) women at screening, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05959304
Study Brief:
Protocol Section:
NCT05959304