Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease

Sponsor
Kantonsspital Aarau
Study ID
NCT02164604
Status
Completed

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
32 Weeks - 40 Weeks
Healthy Volunteers
Not accepted

Interventions

Study Details

Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab. The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.

Key Dates

First listed
Jun 16, 2014
Start date
Jan 31, 2011
Status verified
Jun 2014
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    All eyes receive one intravitreal injection with 0.03ml ranibizumab

Primary Outcome Measure

number of eyes with ocular side effects due to intravitreal ranibizumab [ Time Frame: 6 months ]

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