Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445003
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2007-03-06
Brief Title:
Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2016-08
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:
LRTforDMEPRP
Brief Summary:
The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment At the present time it is not known whether intravitreal steroid or anti-vascular endothelial growth factor anti-VEGF injections are beneficial in preventing vision loss after panretinal photocoagulation PRP treatment It is possible that one or both of the types of injections will prevent vision loss after PRP treatment However it is not known whether the benefits of the injections will outweigh the risks It is possible that because of side effects the injections may not be as good as laser alone in treating the diabetic retinopathy
Detailed Description:
Proliferative diabetic retinopathy PDR is manifested in retinal neovascularization at the disc NVD or elsewhere NVE Vitreous hemorrhage or tractional detachment from PDR is a leading cause of severe visual loss and new onset blindness Without intervention 60 percent of individuals with diabetic retinopathy will eventually develop PDR resulting in significant visual loss in nearly fifty percent
Proliferative diabetic retinopathy is currently treated with panretinal photocoagulation PRP which destroys areas of the retina but preserves central vision PRP is most effectively seen in a regression of new vessels stabilization of the neovascularization and reduced risk of visual loss However the treatment is associated with unavoidable side effects including macular edema with transient or permanent central vision loss diminished vision loss and night vision loss The treatment applies laser burns to the peripheral retinal tissue destroying outer photoreceptors and retinal pigment epithelium of the retina and is thought to exert its effect by increasing oxygen delivery to the inner retina and decreasing viable hypoxic cells which are producing growth factors such as VEGF Studies have implicated vascular endothelial growth factor VEGF as the substance leading to neovascularization andor increased vascular permeability Thus it is reasonable to expect that inhibition of VEGF could reduce both PDR and transient vision loss from macular edema There are several anti-VEGF drugs Ranibizumab is the drug to be evaluated in this trial In one trial of ranibizumab on DME ten patients with chronic DME received a series of 05 mg intraocular injections The treatments were well tolerated with no ocular or systemic adverse events Since intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in all ten patients there is strong rationale to consider this drug as adjunctive therapy to PRP in a attempt to reduce the acute transient edema that may occur with PRP
Similarly corticosteroids a class of substances with anti-inflammatory properties have demonstrated to inhibit the expression of VEGF Triamcinolone acetonide is often used as a periocular injection for the treatment of cystoid macular edema CME secondary to uveitis Clinically triamcinolone acetonide is used in the treatment of proliferative vitreoretinopathy and choroidal neovascularization Studies on patients with proliferative diabetic retinopathy randomly assigned to receive 4 mg triamcinolone 10 to 15 days prior to PRP treatment showed a reduction in central macular thickening and fluorescein leakage was greater in the injection group than in the control group at 9 and 12 months follow up Mean visual acuity improved by one line in the injection group and worsened by two lines in the control group
In summary there is strong rationale that using either intravitreal ranibizumab or intravitreal triamcinolone acetonide as an adjunct to PRP could reduce the magnitude of vision loss
This study is being conducted to determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the occurrence of macular edema and visual acuity impairment following PRP Subjects will be randomly assigned with equal probability to one of the following three injection groups
Intravitreal injection of 05 mg ranibizumab Lucentis at baseline and 4 weeks
Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
Sham injection at baseline and 4 weeks
The initial injection or sham is given on the day of randomization Focal macular photocoagulation is given 7 to 10 days following the injection Panretinal scatter photocoagulation can be initiated either on the same day as the focal photocoagulation immediately following the focal photocoagulation or on a subsequent day but must be initiated within 14 days of the baseline injection Required follow-up visits occur at 4 14 34 and 56 weeks
Proliferative diabetic retinopathy is currently treated with panretinal photocoagulation PRP which destroys areas of the retina but preserves central vision PRP is most effectively seen in a regression of new vessels stabilization of the neovascularization and reduced risk of visual loss However the treatment is associated with unavoidable side effects including macular edema with transient or permanent central vision loss diminished vision loss and night vision loss The treatment applies laser burns to the peripheral retinal tissue destroying outer photoreceptors and retinal pigment epithelium of the retina and is thought to exert its effect by increasing oxygen delivery to the inner retina and decreasing viable hypoxic cells which are producing growth factors such as VEGF Studies have implicated vascular endothelial growth factor VEGF as the substance leading to neovascularization andor increased vascular permeability Thus it is reasonable to expect that inhibition of VEGF could reduce both PDR and transient vision loss from macular edema There are several anti-VEGF drugs Ranibizumab is the drug to be evaluated in this trial In one trial of ranibizumab on DME ten patients with chronic DME received a series of 05 mg intraocular injections The treatments were well tolerated with no ocular or systemic adverse events Since intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in all ten patients there is strong rationale to consider this drug as adjunctive therapy to PRP in a attempt to reduce the acute transient edema that may occur with PRP
Similarly corticosteroids a class of substances with anti-inflammatory properties have demonstrated to inhibit the expression of VEGF Triamcinolone acetonide is often used as a periocular injection for the treatment of cystoid macular edema CME secondary to uveitis Clinically triamcinolone acetonide is used in the treatment of proliferative vitreoretinopathy and choroidal neovascularization Studies on patients with proliferative diabetic retinopathy randomly assigned to receive 4 mg triamcinolone 10 to 15 days prior to PRP treatment showed a reduction in central macular thickening and fluorescein leakage was greater in the injection group than in the control group at 9 and 12 months follow up Mean visual acuity improved by one line in the injection group and worsened by two lines in the control group
In summary there is strong rationale that using either intravitreal ranibizumab or intravitreal triamcinolone acetonide as an adjunct to PRP could reduce the magnitude of vision loss
This study is being conducted to determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the occurrence of macular edema and visual acuity impairment following PRP Subjects will be randomly assigned with equal probability to one of the following three injection groups
Intravitreal injection of 05 mg ranibizumab Lucentis at baseline and 4 weeks
Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
Sham injection at baseline and 4 weeks
The initial injection or sham is given on the day of randomization Focal macular photocoagulation is given 7 to 10 days following the injection Panretinal scatter photocoagulation can be initiated either on the same day as the focal photocoagulation immediately following the focal photocoagulation or on a subsequent day but must be initiated within 14 days of the baseline injection Required follow-up visits occur at 4 14 34 and 56 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10EY014231-09 | NIH | None | httpsreporternihgovquickSearchU10EY014231-09 |
| U10EY018817-03 | NIH | None | None |
| U10EY014229-07 | NIH | None | None |