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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT02134457
Eligibility Criteria:
Inclusion Criteria:
* Bilateral ROP in zone I (stage 1+, 2+, 3+/-, AP-ROP) or ROP in central (=posterior) zone II (stage 3+, AP-ROP). Zone I is defined as twice the distance from the optic disc to the fovea measured temporally, posterior zone II is defined as three times the distance from the optic disc to the fovea measured temporally.
* Legal representatives or their designates willing and able to attend regular study visits with the study infant.
* Written informed consent to participate in the study (signed by all patient's legal representatives).
Exclusion Criteria:
* Pediatric conditions rendering the infant ineligible to anti-VEGF treatment or to repeated blood draws as evaluated by a neonatal ICU specialist and a study ophthalmologist.
* Congenital brain lesions significantly impairing optic nerve function.
* Severe hydrocephalus with significantly increased intracranial pressure.
* Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and 5).
* ROP involving only the peripheral retina (i.e. peripheral zone II or zone III).
* Known hypersensitivity to the study drug or to drugs with similar chemical structures.
* Contraindications for an intravitreal injection as listed in ranibizumab SmPC.
* Systemic use of anti-VEGF therapeutics.
* Use of other investigational drugs - excluding vitamins and minerals - at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02134457
Study Brief:
Protocol Section:
NCT02134457