Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Sponsor
University Hospital Freiburg
Study ID
NCT02134457
Phase
PHASE2
Status
Completed

Conditions

  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
May 9, 2014
Start date
Aug 31, 2014
Status verified
Mar 2017
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.12 mg
    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.
  • Experimental: Ranibizumab 0.20 mg
    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.

Primary Outcome Measure

Efficacy of treatment [ Time Frame: Up to 24 weeks post first injection ]

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