Retinal Blood Flow in Response to an Intravitreal Injection of Ranibizumab for Central Retinal Vein Occlusion (CRVO)
1 other identifier
observational
30
1 country
1
Brief Summary
Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of central retinal vein occlusion, which is one of the most common retinal vascular disorders. Despite its clinical effectiveness, concerns remain regarding the systemic effects of the drug and previous studies have noted retinal arteriolar vasoconstriction following a ranibizumab injection. We aim to provide a physiological basis to these observations by assessing retinal blood flow before and after the ranibizumab injections. Specifically, we will assess the blood flow parameters (i.e. retinal vessel diameter, velocity \& flow) immediately before the first injection and post-injection over a follow-up continued treatment period.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFebruary 24, 2011
February 1, 2011
February 15, 2011
February 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitative change in retinal blood flow
Retinal blood flow will be measured using Canon Laser Blood Flowmeter
Baseline, 7, 30 days
Secondary Outcomes (1)
Best Corrected Visual Acuity (LogMAR, EDTRS)
Baseline, 7, 30 days
Study Arms (2)
Anti-VEGF group
Patients who are clinically indicated for the intravitreal injection of ranibizumab
Age-matched controls
Group of healthy participants who will be age and gender matched
Eligibility Criteria
Patients with central retinal vein occlusion will be recruited from the Retina Clinics of Toronto Western Hospital
You may qualify if:
- Age \> 50 years
- central retinal vein occlusion scheduled for first intravitreal injection of ranibizumab as part of their clinical care
You may not qualify if:
- previous history of intravitreal therapy,
- history of thromboembolic events,
- glaucoma or an intraocular pressure \>21 mmHg
- diabetes mellitus or altered blood viscosity syndromes
- blood donation in the previous 2 weeks
- refractive error of +/- 6.00 DS and/or 2.00 DC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Hudson, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 24, 2011
Study Start
June 1, 2011
Last Updated
February 24, 2011
Record last verified: 2011-02