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Ranibizumab and the Risk of Arterial Thromboembolic Events

NCT01319188 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2015-05-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

0.5 mg of ranibizumab

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).

PROCEDURE

0.5 mg of ranibizumab + photodynamic therapy

Photodynamic treatment with ranibizumab for predominantly classic type neovascular age related macular degeneration.

OTHER

Sham injection

Sham treatment for occult or minimally classic type neovascular age related macular degeneration.

Sponsors & Collaborators

  • Ural Institute of Cardiology

    collaborator OTHER

  • De Haar Research Foundation

    collaborator OTHER

  • Ural State Medical University

    lead OTHER

Principal Investigators

  • Jan Gabinsky, M.D., Ph.D. · Ural Institute of Cardiology

  • Alexander Kharlamov, M.D., Ph.D. · Ural State Medical University

  • Olga Kovtun, M.D., Ph.D. · Ural State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2015-04-30

Countries

  • Netherlands
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319188 on ClinicalTrials.gov