Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387582
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2006-10-11
Brief Title:
Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor:
Rocky Mountain Retina Consultants
Organization:
Rocky Mountain Retina Consultants
Study Overview
Official Title:
Lucentis in the Treatment of Macular Edema - A Phase II Single Center Randomized Study to Evaluate the Efficacy of Ranibizumab Versus Focal Laser Treatment in Subjects With Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab Lucentis in the treatment of Diabetic Macular Edema as compared to gridfocal laser
Detailed Description:
Diabetic macular edema DME results from abnormal leakage of macromolecules into the extracellular space from microaneurysms and incompetent blood vessel walls due to small vessel damage from high blood glucose levels Oncotic forces then allow water into the extracellular space Abnormalities in the retinal pigment epithelium RPE may reduce normal outflow of fluid from the retina to the underlying choriocapillaris via the pump mechanism Ferris et al 1984 This leads to retinal edema in the macula with accompanying loss of vision There is evidence suggesting that vascular endothelial growth factor VEGF plays a part in vessel wall permeability with subsequent retinal edema Aiello et al 1997
Studies demonstrate that tight junctions in the vessel walls were shown to be regulated by VEGF and VEGF increases vascular permeability Anticliff et al 1999 The healthy human retina contains little or no VEGF Hypoxia a component of diabetic retinopathy causes upregulation of VEGF in the retina Vinores et al 1997 Binding VEGF with an antibody specific for VEGF may inhibit resultant edema thus preventing and possibly reversing loss of vision
Diabetic retinopathy is the leading cause of blindness in people aged 20-74 years accounting for 8 of all cases of legal blindness and 12 of the newly blind Klein 1995 A common complication of all forms of diabetes mellitus diabetic retinopathy is present in over 25 of the US population or more than 53 million people aged 18 or older Prevent Blindness American 2002
Three forms of retinopathy are commonly recognized in association with all forms of diabetes mellitus 1 non-proliferative diabetic retinopathy NPDR 2 proliferative diabetic retinopathy PDR and 3 diabetic macular edema DME
NPDR is characterized by ophthalmoscopically visable abnormalities that include microaneurysms intraretinal hemorrhages exudates retina nerve fiber layer infarcts cotton-wool spots and in more severe cases venous beading and intraretinal microvascular abnormalities IRMA
Over time NPDR may progress to more severe PDR the hallmark of which is neovascularization on the surface of the retina optic disc or iris and angle structures in the front of the eye PDR is associated with a high risk of visual morbidity arising from vitreous hemorrhage traction retinal detachment and neovascular glaucoma Diabetic Retinopathy Research Group 1979
DME the third form of diabetic retinopathy is characterized by swelling of the central part of the retina that mediates high-resolution vision DME frequently coexists with and is superimposed upon NPDR or PDR When the area of swelling is located more than 1 disc diameter approximately 1500 mm away from the center of the fovea the swelling constitutes a low threat to visual acuity and is regarded as non-clinically significant macular edema Early Treatment Diabetic Retinopathy Study ETDRS Research Group 1985 Vision deteriorates when DME involves the foveal center DME that either directly involves the fovea or is at high risk of doing so is referred to as Clinically Significant Macular Edema CSME ETDRS Research Group 1985
When the center of the fovea is involved by CSME the DME is referred to as CSME with center involvement CSME-CI as opposed to CSME without center involvement ETDRS Research Group 1987
The natural history of untreated CSME-CI is particularly poor The ETDRS demonstrated that over a 3-year period 33 of subjects with CSME-CI lose 15 letters of visual acuity on the standardized ETDRS Visual Acuity Chart Ferris et al 1982 compared with 23 of CSME subjects without center involvement ETDRS Research Group 1987 Such a degree of visual acuity change is equivalent to doubling of the visual angle or greater The ETDRS did not discriminate between subtypes of diabetes mellitus
Although laser photocoagulation in CSME-CI was shown to reduce the proportion of subjects losing 15 letters from 33 to 13 over 3 years 13 of subjects nevertheless continued to double their visual angle or do worse Moreover in subjects with CSME initially without center involvement over 3 years 12 lose 15 letters despite laser treatment presumably because edema eventually involves the center of the fovea ie the subjects convert to CSME-CI Thus while laser is an effective tool in the treatment of CSME there is a considerable unmet clinical need for CSME-CI
This study is designed to compare the effectiveness of intra-vitreal Ranibizumab to current standard of care
Studies demonstrate that tight junctions in the vessel walls were shown to be regulated by VEGF and VEGF increases vascular permeability Anticliff et al 1999 The healthy human retina contains little or no VEGF Hypoxia a component of diabetic retinopathy causes upregulation of VEGF in the retina Vinores et al 1997 Binding VEGF with an antibody specific for VEGF may inhibit resultant edema thus preventing and possibly reversing loss of vision
Diabetic retinopathy is the leading cause of blindness in people aged 20-74 years accounting for 8 of all cases of legal blindness and 12 of the newly blind Klein 1995 A common complication of all forms of diabetes mellitus diabetic retinopathy is present in over 25 of the US population or more than 53 million people aged 18 or older Prevent Blindness American 2002
Three forms of retinopathy are commonly recognized in association with all forms of diabetes mellitus 1 non-proliferative diabetic retinopathy NPDR 2 proliferative diabetic retinopathy PDR and 3 diabetic macular edema DME
NPDR is characterized by ophthalmoscopically visable abnormalities that include microaneurysms intraretinal hemorrhages exudates retina nerve fiber layer infarcts cotton-wool spots and in more severe cases venous beading and intraretinal microvascular abnormalities IRMA
Over time NPDR may progress to more severe PDR the hallmark of which is neovascularization on the surface of the retina optic disc or iris and angle structures in the front of the eye PDR is associated with a high risk of visual morbidity arising from vitreous hemorrhage traction retinal detachment and neovascular glaucoma Diabetic Retinopathy Research Group 1979
DME the third form of diabetic retinopathy is characterized by swelling of the central part of the retina that mediates high-resolution vision DME frequently coexists with and is superimposed upon NPDR or PDR When the area of swelling is located more than 1 disc diameter approximately 1500 mm away from the center of the fovea the swelling constitutes a low threat to visual acuity and is regarded as non-clinically significant macular edema Early Treatment Diabetic Retinopathy Study ETDRS Research Group 1985 Vision deteriorates when DME involves the foveal center DME that either directly involves the fovea or is at high risk of doing so is referred to as Clinically Significant Macular Edema CSME ETDRS Research Group 1985
When the center of the fovea is involved by CSME the DME is referred to as CSME with center involvement CSME-CI as opposed to CSME without center involvement ETDRS Research Group 1987
The natural history of untreated CSME-CI is particularly poor The ETDRS demonstrated that over a 3-year period 33 of subjects with CSME-CI lose 15 letters of visual acuity on the standardized ETDRS Visual Acuity Chart Ferris et al 1982 compared with 23 of CSME subjects without center involvement ETDRS Research Group 1987 Such a degree of visual acuity change is equivalent to doubling of the visual angle or greater The ETDRS did not discriminate between subtypes of diabetes mellitus
Although laser photocoagulation in CSME-CI was shown to reduce the proportion of subjects losing 15 letters from 33 to 13 over 3 years 13 of subjects nevertheless continued to double their visual angle or do worse Moreover in subjects with CSME initially without center involvement over 3 years 12 lose 15 letters despite laser treatment presumably because edema eventually involves the center of the fovea ie the subjects convert to CSME-CI Thus while laser is an effective tool in the treatment of CSME there is a considerable unmet clinical need for CSME-CI
This study is designed to compare the effectiveness of intra-vitreal Ranibizumab to current standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None