retinopathy of prematurity MedDRA version: 20.1 Level: LLT Classification code 10038974 Term: Retrolental fibroplasia System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Lucentis
Product Name: Ranibizumab
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml milli
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. Treatment zones will be documented with a RetCam (if available). 2. Legal representatives or their designates willing and able to attend regular study visits with the study infant. 3. Written informed consent to participate in the study (signed by all patient’s legal representatives) Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Congenital brain lesions significantly impairing optic nerve function. 3. Severe hydrocephalus with significantly increased intracranial pressure. 4. Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and 5). 5. ROP involving only the peripheral retina (i.e. peripheral zone II or zone III). 6. Known hypersensitivity to the study drug or to drugs with similar chemical structures. 7. Contraindications for an intravitreal injection as listed in ranibizumab SmPC. 8. Systemic use of anti-VEGF therapeutics. 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess clinical efficacy of ranibizumab in children with ROP. Efficacy is determined by the number of infants without need for rescue treatment up to week 24 post first injection. Re-injection of study dose is not considered rescue treatment if applied after an initial response to treatment and after at least 4 weeks post injection.;Secondary Objective: - To assess regression of plus disease during core study - To assess regression of preretinal vascularized ridge during core study - To assess progression of peripheral intraretinal vascularization beyond ridge during core study - Safety determined by number and kind of AEs and SAEs per group during core study - To compare the changes in vascular endothelial growth factor (VEGF) levels in the systemic circulation during core study - To assess the number of re-injections of study dose during core study - To assess the number of patients progressing to stage 4 or 5 ROP during core study - To assess the number of patients with complete vascularization of the peripheral retina to within one disc diameter of the ora serrata during core study ;Primary end point(s): number of infants without need for rescue treatment ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of infants with regression of plus disease, regression of preretinal vascularized ridge, and progression of peripheral intraretinal vascularization beyond ridge during core study - Number of patients progressing to stage 4 or 5 ROP during core study - Number of patients with complete vascularization of the peripheral retina to within one disc diameter of the ora serrata during core study - The number of ranibizumab regular (re-)injections during the core study as well as the time to (regular) re-injections;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Germany
Contacts
Public Contactmedical director
University Eye Hospital Greifwald
Outcome results
None listed