Status:
COMPLETED
Lucentis to Treat Pigment Epithelial Detachment
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Pigment Epithelial Detachment
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a b...
Detailed Description
Background: Exudative Age Related Macular Degeneration (AMD) results in a significant and severe visual loss if left untreated as documented in natural history and observational arms of studies such ...
Eligibility Criteria
Inclusion
- Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
- PED under the geometric center of the foveal avascular zone.
- Evidence of recent disease progression as suggested by one or more of the following: sub-retinal lipid or cystic macular edema, sub-retinal hemorrhage, vision loss within the last 3 months or documented lesion growth on FA over previous 6 months.
- Visual acuity of between 20/40 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 meters.
- Ambulatory Vision in the fellow eye
- Willingness and ability to participate and provide written informed consent.
Exclusion
- Individuals with choroidal neovascularization from causes other than AMD.
- Patients physically unable to tolerate intravenous fluorescein angiography
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
- Individuals with physical or mental disabilities that prevent accurate vision testing.
- History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
- Prior photodynamic therapy for CNV.
- Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- Women of childbearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medication.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00841581
Start Date
December 1 2008
End Date
December 1 2011
Last Update
December 8 2011
Active Locations (1)
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1
Ivey Eye Institute
London, Ontario, Canada, N6A 4G5