CompletedPhase 2

Lucentis to Treat Pigment Epithelial Detachment

Canada32 participantsStarted 2008-12

Plain-language 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 baseline evaluation.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart.

Timeframe: 6 months

Trial details

NCT IDNCT00841581

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09

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