This study is to determine if ranibizumab injected into the eye is superior to laser therapy in the treatment of retinopathy of prematurity (ROP). The study will assess the ability of these treatments to lead to regression of active ROP and prevent the development of ocular complications that are associated with poor visual outcome.

• Register: EUCTR
• Last refreshed on: 16 May 2022
• Main ID: EUCTR2014-004048-36-CZ
• Date of registration: 26/04/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: This study is to determine if ranibizumab injected into the eye is superior to laser therapy in the treatment of retinopathy of prematurity (ROP). The study will assess the ability of these treatments to lead to regression of active ROP and prevent the development of ocular complications that are associated with poor visual outcome.
• Scientific title: RAINBOW extension study: an extension study to evaluate the long term efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematurity - RAINBOW Extension study
• Date of first enrolment: 15/06/2016
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004048-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Croatia, Czech Republic, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Malaysia, Poland, Romania, Russian Federation, Saudi Arabia, Slovakia, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Informacní služba – klin. hodnocení
• Affiliation: Novartis s.r.o.

• Name: Informacní služba – klin. hodnocení
• Affiliation: Novartis s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
The patient successfully completed the core study CRFB002H2301
The patient received study treatment in both eyes at baseline of study CRFB002H2301
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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:
Patient has a medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
Patient has been discontinued from the core study CRFB002H2301 at any time

Other protocol-defined inclusion/exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Retinopathy of Prematurity (ROP)
MedDRA version: 20.1 Level: PT Classification code 10038933 Term: Retinopathy of prematurity System Organ Class: 10015919 - Eye disorders

Intervention(s)

Trade Name: Lucentis
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: RFB002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To assess visual function of the better seeing eye

Timepoint(s) of evaluation of this end point: VA is being assessed at the patient's fifth birthday.

Secondary Objective: To assess:
- number of patients having any ocular Adverse Event
- number of patients having any systemic Adverse Event
- visual function of the worse seeing eye
- absence of active Retinopathy of Prematurity
- absence of ocular structural abnormalities
- recurrence of ROP
- number of Lucentis administrations
- refraction in each eye
- standing/sitting height and leg length
- weight
- head circumference
- respiratory function
- hearing function
- duration of hospitalization
- weight at first hospital discharge

Primary end point(s): Visual acuity (VA) in the better-seeing eye

Secondary Outcome(s)

Secondary end point(s): Ocular Adverse Events
Systemic Adverse Events
VA of the worse-seeing eye
Active ROP
Ocular structural abnormalities
Recurrence of ROP
Lucentis administrations
Refraction
Height/leg length
Weight
Head circumference
Respiratory function
Hearing function
Hospitalization (duration)
Weight (discharge)

Timepoint(s) of evaluation of this end point: At the patient's fifth birthday
At the patient's fifth birthday
At the patient's fifth birthday
40 and 52 weeks after initial treatment
40 and 52 weeks after initial treatment, at patient's two years corrected age and fifth birthday
40 and 52 weeks after initial treatment
40 weeks after initial treatment
At patient's two years corrected age and fifth birthday
At patient's two years corrected age and fifth birthday
At patient's two years corrected age and fifth birthday
at patient's two years corrected age
At patient's two years corrected age and fifth birthday
At patient's two years corrected age and fifth birthday
At patient's two years corrected age and fifth birthday
At patient's two years corrected age and fifth birthday

Secondary ID(s)

2014-004048-36-HU

CRFB002H2301E1

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 11/05/2016
Contact: