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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT05576792
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
2. Male or female preterm infants with a birth weight of less than 1500 g
3. Bilateral ROP with 1 of the following retinal findings in each eye:
* Zone I, stage 1+, 2+, 3 or 3+ disease, or
* Zone II, stage 3+ disease, or
* A-ROP
Exclusion Criteria:
1. Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
2. Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
3. Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
4. Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
5. Participants who have contraindications according to locally approved ranibizumab label
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Study:
NCT05576792
Study Brief:
Protocol Section:
NCT05576792