Study Stopped
The study was terminated under the political pressure of the Federal Security Service of the Russian Federation (FSB) and the Russian Society of Cardiology
Ranibizumab and the Risk of Arterial Thromboembolic Events
RATE
Ranibizumab for Age-Related Macular Degeneration and the Risk of Arterial Thromboembolic Events (RATE)
1 other identifier
interventional
380
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 19, 2015
May 1, 2015
2.3 years
March 18, 2011
May 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arterial thromboembolic events rate
This is a combined primary outcome that included: * all cause mortality * nonfatal stroke * nonfatal myocardial infarction * vascular death
at month 6, 12 and 24
Secondary Outcomes (11)
Serum concentration of ranibizumab
at month 6, 12 and 24
Serum VEGF
at month 6, 12 and 24
Mean change in visual acuity (letters)
at month 6, 12 an 24
Coronary and/or cerebral stenting, and/or CABG rate
at month 6, 12 an 24
Total cholesterol
at month 6, 12 and 24
- +6 more secondary outcomes
Study Arms (3)
0.5 mg of ranibizumab
ACTIVE COMPARATORinjection + photodynamic therapy
ACTIVE COMPARATORSham injection
SHAM COMPARATORInterventions
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).
Photodynamic treatment with ranibizumab for predominantly classic type neovascular age related macular degeneration.
Sham treatment for occult or minimally classic type neovascular age related macular degeneration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ural State Medical Universitylead
- Ural Institute of Cardiologycollaborator
- De Haar Research Foundationcollaborator
Study Sites (2)
De Haar Research Foundation
Rotterdam, South Holland, 3071PR, Netherlands
Ural Institute of Cardiology
Yekaterinburg, 620144, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Gabinsky, M.D., Ph.D.
Ural Institute of Cardiology
- STUDY DIRECTOR
Alexander Kharlamov, M.D., Ph.D.
Ural State Medical University
- PRINCIPAL INVESTIGATOR
Olga Kovtun, M.D., Ph.D.
Ural State Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Assistant of C.E.O., Ural Institute of Cardiology
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 21, 2011
Study Start
June 1, 2010
Primary Completion
October 1, 2012
Study Completion
April 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05