Ranibizumab and the Risk of Arterial Thromboembolic Events

Sponsor
Ural State Medical University
Study ID
NCT01319188
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 0.5 mg of ranibizumab — DRUG
    Intravitreous ranibizumab (0.5 mg, injections at four week intervals for six months followed by further treatment at three month intervals with total duration of treatment until 24 months).
  • 0.5 mg of ranibizumab + photodynamic therapy — PROCEDURE
    Photodynamic treatment with ranibizumab for predominantly classic type neovascular age related macular degeneration.
  • Sham injection — OTHER
    Sham treatment for occult or minimally classic type neovascular age related macular degeneration.

Study Details

The investigators assume that ranibizumab might be dangerous in patients with history of coronary artery disease or cerebrovascular events. The main objective of study is to reveal contraindications for ranibizumab prescription in patients with history of coronary artery disease and cerebrovascular events. Moreover, an association between management with ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great interest as well.

Key Dates

First listed
Mar 21, 2011
Start date
Jun 30, 2010
Status verified
May 2015
Primary completion
Oct 31, 2012
Completion
Apr 30, 2015

Study Design

Enrollment
380 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: 0.5 mg of ranibizumab
  • Active Comparator: injection + photodynamic therapy
  • Sham Comparator: Sham injection

Primary Outcome Measure

Arterial thromboembolic events rate [ Time Frame: at month 6, 12 and 24 ]

Related Studies