Ranibizumab and the Risk of Arterial Thromboembolic Events

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ural Medical University; Ural State Medical University
• Collaborators: De Haar Research Foundation; Ural Institute of Cardiology
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• age - 50 years old and older

• male and female

• age-related macular degeneration (AMD)

• have a lesion in the study eye with a total size of less than 12 optic disc areas for minimally classic or occult lesions but no more than 5400 μm in greatest linear dimension for predominantly classic lesions

• have best corrected visual acuity of 6/12 to approximately 6/96 (Snellen equivalent), assessed with the use of charts from the Early Treatment Diabetic Retinopathy Study (ETDRS) (70 to 25 ETDRS 1 m equivalent letter scores; patients initially view the charts at a starting distance of 4 m, the number of correctly read letters are given a correction factor with the final letter score being the equivalent of a patient reading it at 1m. A score of 55 letters approximates to 6/24 Snellen acuity)

• have no permanent structural damage to the central fovea

• have had no previous treatment for exudative age related macular degeneration

• healthy subjects (no history of cardio- or cerebrovascular events), or history of coronary artery disease (cardiovascular events - myocardial infarction, unstable angina), or history of cerebrovascular events (brain ischemia, and/or stroke), but not in the preceding six months

Exclusion Criteria:

• history of cardiovascular events (myocardial infarction, unstable angina) or cerebrovascular events in the preceding six months

• stenting, or any surgery in the preceding six months

• other acute illnesses in the preceding three months

• III-IV NYHA functional class of heart failure

• mental and brain disorders

• pregnancy

• family hypercholesterolemia

• blood disorders

• malignant tumors

• participation to any drug investigation during the previous three months