Status:
COMPLETED
Lucentis for Treatment of Macular Edema
Lead Sponsor:
Retina Institute of Hawaii
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Cystoid Macular Edema
Eligibility:
All Genders
Up to 90 years
Brief Summary
Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions. Over two million cataract extractions are performed each year, wi...
Detailed Description
Vascular endothelial growth factor (VEGF) is known to be induced by hypoxia and has been implicated in the development of iris and retinal vascularization. VEGF, however, is also known to be a potent ...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \< 90 years
- Cystoid macular edema, documented by FFA
- Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/30 and 20/800 in a Snellen chart.
- Women must be using two forms of effective contraception, be post¬menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
Exclusion
- Significant media opacities, which might interfere with visual acuity.
- Any ocular or periocular infection in the past 4 weeks.
- Presence of pigment epithelial tears or rips.
- Any of the following underlying diseases including:
- Diabetic retinopathy.
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment.
- History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- History or evidence of clinically significant impaired renal or hepatic function
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry.
- Previous therapeutic radiation in the region of the study eye.
- Any treatment with an investigational agent in the past 30 days for any condition.
- Known serious allergies to the fluorescein dye used in angiography or to the components of ranibizumab formulation.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00464581
Start Date
May 1 2007
End Date
December 1 2009
Last Update
May 28 2012
Active Locations (1)
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1
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815