An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01908816
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

Study Details

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Key Dates

First listed
Jul 26, 2013
Start date
Sep 26, 2013
Status verified
Jul 2019
Primary completion
Jan 8, 2016
Completion
Jan 8, 2016

Study Design

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

Arms

  • Experimental: ranibizumab
    0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.

Primary Outcome Measure

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 months ]

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