Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP)

University Hospital Freiburg

Status and phase: Completed; Phase 2

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Biological: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02134457

2013-002539-13 (EudraCT Number)

CARE-ROP

Details and patient eligibility

About

This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates.

The primary objective is to assess clinical efficacy of ranibizumab in children with ROP

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

19 participants in 2 patient groups

Ranibizumab 0.12 mg

Experimental group

Description:

20 µl of the 6 mg/ml ranibizumab concentration will be applied intravitreally. After an initial response the same dose as in the first injection can be re-applied after at least four weeks post injection. A maximum number of 3 regular re-injections can be applied.

Treatment:

Biological: ranibizumab

Ranibizumab 0.20 mg

Experimental group

Description:

20 µl of the 10 mg/ml ranibizumab concentration will be applied intravitreally. After an initial response the same dose as in the first injection can be re-applied after at least four weeks post injection. A maximum number of 3 re-injections can be applied.

Treatment:

Biological: ranibizumab