Lucentis to Treat Pigment Epithelial Detachment
This study has been completed.
Information provided by (Responsible Party):
Thomas G. Sheidow, Lawson Health Research Institute
First received: February 9, 2009
Last updated: December 7, 2011
Last verified: December 2011
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.
Pigment Epithelial Detachment
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Intravitreal Lucentis (iL) (Ranibizumab) for the Treatment of AMD Related Pigment Epithelial Detachment (PED)
Primary Outcome Measures:
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on lesion growth and activity over the study period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on lesion growth and activity over the study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
All patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations.
Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00841581
|Ivey Eye Institute
|London, Ontario, Canada, N6A 4G5 |
Lawson Health Research Institute
||Thomas G Sheidow, MD
||Ivey Eye Institute, LOndon, Ontario, Canada
No publications provided
||Thomas G. Sheidow, Vitreoretinal Surgeon, Associate professor of Ophthalmology, Lawson Health Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 9, 2009
||December 7, 2011
||Canada: Ethics Review Committee
Keywords provided by Lawson Health Research Institute:
Age Related Macular Degeneration
Pigment Epithelial Detachment
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014