Lucentis to Treat Pigment Epithelial Detachment

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Feb 9, 2009

Keywords

ClinConnect Summary

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 as the macular photocoagulation study (MPS) and the Tap and VIP study with Visudyne. It is also clear however, that the different lesion types (classified by intravenous fluorescein angiography ((IVFA)) as occult, minimally classic or predominately classic) have both a different natural history and a different response to treatment.

The recent introduction of the anti-VEGF agents such as Macug...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
• • 2. PED under the geometric center of the foveal avascular zone.
• • 3. 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.
• • 4. 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.
• • 5. Ambulatory Vision in the fellow eye
• • 6. Willingness and ability to participate and provide written informed consent.
• Exclusion Criteria:
• • 1. Individuals with choroidal neovascularization from causes other than AMD.
• • 2. Patients physically unable to tolerate intravenous fluorescein angiography
• • 3. Any intraocular surgery within 2 months in the study eye.
• • 4. Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
• • 5. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
• • 6. Individuals with physical or mental disabilities that prevent accurate vision testing.
• • 7. History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
• • 8. Prior photodynamic therapy for CNV.
• • 9. Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
• • 10. 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.