Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231023
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-10-02
Brief Title:
Triamcinolone Acetonide Injections to Treat Diabetic Macular Edema
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2006-05
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 which of the three following treatment options is better for diabetic macular edema laser alone steroid injection alone or steroid injection followed by laser Macular edema is a swelling in the small central part of the retina - the part of the retina that is used for sharp straight-ahead vision Laser treatment is the only treatment that has been proven to be beneficial for diabetic macular edema It reduces the swelling and lessens the chance of further vision loss but it does not improve vision Triamcinolone is a steroid drug that decreases inflammation and scarring Injections of the drug have decreased macular edema in some patients and improved vision Swelling may return requiring repeat injections and it is not known if the vision improvement is permanent This 3-year study will examine and compare the benefits and side effects of both treatments alone and in combination
Patients 18 years of age and older with diabetic macular edema may be eligible for this study Participants undergo the following tests and procedures
At the beginning of the study
Blood tests to measure HbA1C measure of diabetes control
Measurement of blood pressure
Eye examination to assess visual acuity eye chart test and eye pressure and to examine pupils lens retina and eye movements The pupils are dilated with drops for this examination
Optical coherence tomography OCT to measure retinal thickness This test shines a light into the eye and produces cross-sectional pictures of the retina These measurements are repeated during the study to determine if retinal thickening is getting better or worse or staying the same
Photographs of the retina and lens A special camera with bright flashes is used to take these photographs
Treatments
Some patients will have one eye treated and some patients will have both eyes treated The treatment for a given individual is determined by chance
Triamcinolone acetonide injection alone The steroid is injected in the tissue around the eye Two injection procedures are used in the study differing in their location and dose Numbing drops are placed over the area to be injected and the steroid is injected
Laser treatment alone The surface of the eye is numbed with drops and a contact lens is placed on the eye during the laser beam application Before the treatment patients may have fluorescein angiography in which pictures of the retina are taken using a yellow dye The dye is injected into a vein and travels to the blood vessels in the eye The camera flashes a blue light in the eye and takes pictures that show the amount of dye leakage into the retina Treatments may be repeated at several visits
Triamcinolone acetonide plus laser treatment Patients who receive both the steroid injection and laser have the steroid injection first and the laser treatment 1 month later
Follow-up
Patients return to the clinic for follow-up visits at 1 2 4 8 12 24 and 36 months or more often if needed after the initial treatment for an eye exam measurement of visual acuity and OTC Photographs of the retina are taken at the 4- and 8-month visits and at the 1- 2- and 3-year visits Fluorescein angiography may be done at 4 months Blood pressure is measured at the 1- 2- and 3-year visits and an HbA1c blood test is done at 4 and 8 months and at the yearly visits Participants may be asked to complete a questionnaire once a year about their vision and medical condition Treatment options are discussed at the 4- and 8-month visits
Patients 18 years of age and older with diabetic macular edema may be eligible for this study Participants undergo the following tests and procedures
At the beginning of the study
Blood tests to measure HbA1C measure of diabetes control
Measurement of blood pressure
Eye examination to assess visual acuity eye chart test and eye pressure and to examine pupils lens retina and eye movements The pupils are dilated with drops for this examination
Optical coherence tomography OCT to measure retinal thickness This test shines a light into the eye and produces cross-sectional pictures of the retina These measurements are repeated during the study to determine if retinal thickening is getting better or worse or staying the same
Photographs of the retina and lens A special camera with bright flashes is used to take these photographs
Treatments
Some patients will have one eye treated and some patients will have both eyes treated The treatment for a given individual is determined by chance
Triamcinolone acetonide injection alone The steroid is injected in the tissue around the eye Two injection procedures are used in the study differing in their location and dose Numbing drops are placed over the area to be injected and the steroid is injected
Laser treatment alone The surface of the eye is numbed with drops and a contact lens is placed on the eye during the laser beam application Before the treatment patients may have fluorescein angiography in which pictures of the retina are taken using a yellow dye The dye is injected into a vein and travels to the blood vessels in the eye The camera flashes a blue light in the eye and takes pictures that show the amount of dye leakage into the retina Treatments may be repeated at several visits
Triamcinolone acetonide plus laser treatment Patients who receive both the steroid injection and laser have the steroid injection first and the laser treatment 1 month later
Follow-up
Patients return to the clinic for follow-up visits at 1 2 4 8 12 24 and 36 months or more often if needed after the initial treatment for an eye exam measurement of visual acuity and OTC Photographs of the retina are taken at the 4- and 8-month visits and at the 1- 2- and 3-year visits Fluorescein angiography may be done at 4 months Blood pressure is measured at the 1- 2- and 3-year visits and an HbA1c blood test is done at 4 and 8 months and at the yearly visits Participants may be asked to complete a questionnaire once a year about their vision and medical condition Treatment options are discussed at the 4- and 8-month visits
Detailed Description:
Diabetic retinopathy is a major cause of visual impairment in the United States Diabetic macular edema DME is a manifestation of diabetic retinopathy that produces loss of central vision Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy WESDR estimate that after 15 years of known diabetes the prevalence of diabetic macular edema is approximately 20 in patients with type 1 diabetes mellitus DM 25 in patients with type 2 DM who are taking insulin and 14 in patients with type 2 DM who do not take insulin
In a review of three early studies concerning the natural history of diabetic macular edema Ferris and Patz found that 53 of 135 eyes with diabetic macular edema presumably all involving the center of the macula lost two or more lines of visual acuity over a two year period In the Early Treatment Diabetic Retinopathy Study ETDRS 33 of 221 untreated eyes available for follow-up at the 3-year visit all with edema involving the center of the macula at baseline had experienced a 15 or more letter decrease in visual acuity score equivalent to a doubling of the visual angle eg 2025 to 2050 and termed moderate visual loss
In the ETDRS focalgrid photocoagulation of eyes with clinically significant macular edema CSME reduced the risk of moderate visual loss by approximately 50 from 24 to 12 three years after initiation of treatment Therefore 12 of treated eyes developed moderate visual loss in spite of treatment Furthermore approximately 40 of treated eyes that had retinal thickening involving the center of the macula at baseline still had thickening involving the center at 12 months as did 25 of treated eyes at 36 months
Although several treatment modalities are currently under investigation the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation as demonstrated by the ETDRS and intensive glycemic control as demonstrated by the Diabetes Control and Complications Trial DCCT and the United Kingdom Prospective Diabetes Study UKPDS In the DCCT intensive glucose control reduced the risk of onset of diabetic macular edema by 23 compared with conventional treatment Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control with a 58 risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study
The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities One such treatment is pars plana vitrectomy These studies suggest that vitreomacular traction or the vitreous itself may play a role in increased retinal vascular permeability Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity However this treatment may be applicable only to a specific subset of eyes with diabetic macular edema It also requires a complex surgical intervention with its inherent risks recovery time and expense Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor VEGF are under investigation
The use of intravitreal corticosteroids is another treatment modality that has generated recent interest However use of intravitreal corticosteroids generally has been reserved for cases of DME in which there is at least moderate loss of visual acuity eg worse than 2040 This treatment generally has not been widely used for mild cases of DME due to concerns about its potential risks particularly glaucoma and cataract relative to the potential benefit
Injection of corticosteroids around the eye anterior subtenons posterior subtenons retrobulbar has been used as an alternative to intravitreal injection Although data are limited it is presumed that the adverse effects on the eye are lower with an injection around the eye compared with in the eye There are also little data on the efficacy of this treatment This study is being conducted to collect pilot data on the safety and efficacy of peribulbar corticosteroids to determine whether there is sufficient evidence of efficacy to merit conducting a phase 3 randomized trial
In a review of three early studies concerning the natural history of diabetic macular edema Ferris and Patz found that 53 of 135 eyes with diabetic macular edema presumably all involving the center of the macula lost two or more lines of visual acuity over a two year period In the Early Treatment Diabetic Retinopathy Study ETDRS 33 of 221 untreated eyes available for follow-up at the 3-year visit all with edema involving the center of the macula at baseline had experienced a 15 or more letter decrease in visual acuity score equivalent to a doubling of the visual angle eg 2025 to 2050 and termed moderate visual loss
In the ETDRS focalgrid photocoagulation of eyes with clinically significant macular edema CSME reduced the risk of moderate visual loss by approximately 50 from 24 to 12 three years after initiation of treatment Therefore 12 of treated eyes developed moderate visual loss in spite of treatment Furthermore approximately 40 of treated eyes that had retinal thickening involving the center of the macula at baseline still had thickening involving the center at 12 months as did 25 of treated eyes at 36 months
Although several treatment modalities are currently under investigation the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation as demonstrated by the ETDRS and intensive glycemic control as demonstrated by the Diabetes Control and Complications Trial DCCT and the United Kingdom Prospective Diabetes Study UKPDS In the DCCT intensive glucose control reduced the risk of onset of diabetic macular edema by 23 compared with conventional treatment Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control with a 58 risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study
The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities One such treatment is pars plana vitrectomy These studies suggest that vitreomacular traction or the vitreous itself may play a role in increased retinal vascular permeability Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity However this treatment may be applicable only to a specific subset of eyes with diabetic macular edema It also requires a complex surgical intervention with its inherent risks recovery time and expense Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor VEGF are under investigation
The use of intravitreal corticosteroids is another treatment modality that has generated recent interest However use of intravitreal corticosteroids generally has been reserved for cases of DME in which there is at least moderate loss of visual acuity eg worse than 2040 This treatment generally has not been widely used for mild cases of DME due to concerns about its potential risks particularly glaucoma and cataract relative to the potential benefit
Injection of corticosteroids around the eye anterior subtenons posterior subtenons retrobulbar has been used as an alternative to intravitreal injection Although data are limited it is presumed that the adverse effects on the eye are lower with an injection around the eye compared with in the eye There are also little data on the efficacy of this treatment This study is being conducted to collect pilot data on the safety and efficacy of peribulbar corticosteroids to determine whether there is sufficient evidence of efficacy to merit conducting a phase 3 randomized trial
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 |
|---|---|---|---|
| 05-EI-0251 | None | None | None |