Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346983
Status:
TERMINATED
Last Update Posted:
2008-05-12
First Post:
2006-06-29
Brief Title:
Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Pilot Study of the Effect of Pegaptanib Sodium to Prevent Worsening of Cystoid Macular Edema Following Cataract Surgery in Diabetics
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty enrolling eligible subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being conducted to look at the effects of an intraocular drug pegaptanib also called Macugen for the treatment of swelling in the retina the light sensitive tissue in the back of the eye that often occurs following cataract surgery in patients with diabetic eye disease Swelling in the retina can lead to blurry vision and Macugen may reduce this swelling Eyedrops that decrease inflammation also may help to stop some of the swelling We are testing this drug pegaptanib to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having cataract surgery
Detailed Description:
Macular edema occurs as a complication of cataract surgery in approximately 2 of all surgeries In this condition cystic fluid-filled spaces develop in the outer plexiform layer of the retina resulting in a loss of vision This condition is termed Cystoid Macular Edema CME In non-diabetics the majority of such cases resolve spontaneously
Diabetic macular edema DME is an important cause of visual disability among patients with diabetes It is widely recognized that cataract surgery often triggers severe CME in patients with pre-existing DME This exacerbation begins immediately following cataract surgery and unlike in non-diabetics the edema is likely to be protracted and poorly responsive both to traditional treatments for CME topical NSAIDS and DME laser photocoagulation Fluorescein angiography a photographic test that evaluates the blood circulation in the back of the eye has demonstrated that both CME and DME are associated with increased permeability of retinal blood vessels
The high rates and severity of post-cataract surgery CME in diabetic patients with DME render this population ideal for the study of potential agents to reduce the rate and severity of this condition ie post-cataract surgery CME Recent studies have shown that vascular endothelial growth factor VEGF plays a major role in vessel permeability Pegaptanib Macugen is an FDA-approved drug for wet AMD Pegaptanib is a selective VEGF antagonist that blocks the effects of VEGF therefore pegaptanib might decrease vessel permeability and possibly decrease the incidence and severity of CME We plan to conduct a controlled pilot study to investigate the effects of pegaptanib up to 3 treatments of pegaptanib given prior to cataract surgery and as often as every 6 weeks for up to 12 weeks after cataract surgery in diabetic patients with pre-existing DME who are undergoing cataract surgery and who are therefore at very high risk for development of CME Should the pilot study indicate a potential benefit of pegaptanib in this setting a larger fully powered clinical trial will be proposed An effective treatment or preventive measure for post-cataract surgery macular edema in patients with diabetic retinopathy would offer benefit to a large patient population nationally that is at high risk of vision loss
Diabetic macular edema DME is an important cause of visual disability among patients with diabetes It is widely recognized that cataract surgery often triggers severe CME in patients with pre-existing DME This exacerbation begins immediately following cataract surgery and unlike in non-diabetics the edema is likely to be protracted and poorly responsive both to traditional treatments for CME topical NSAIDS and DME laser photocoagulation Fluorescein angiography a photographic test that evaluates the blood circulation in the back of the eye has demonstrated that both CME and DME are associated with increased permeability of retinal blood vessels
The high rates and severity of post-cataract surgery CME in diabetic patients with DME render this population ideal for the study of potential agents to reduce the rate and severity of this condition ie post-cataract surgery CME Recent studies have shown that vascular endothelial growth factor VEGF plays a major role in vessel permeability Pegaptanib Macugen is an FDA-approved drug for wet AMD Pegaptanib is a selective VEGF antagonist that blocks the effects of VEGF therefore pegaptanib might decrease vessel permeability and possibly decrease the incidence and severity of CME We plan to conduct a controlled pilot study to investigate the effects of pegaptanib up to 3 treatments of pegaptanib given prior to cataract surgery and as often as every 6 weeks for up to 12 weeks after cataract surgery in diabetic patients with pre-existing DME who are undergoing cataract surgery and who are therefore at very high risk for development of CME Should the pilot study indicate a potential benefit of pegaptanib in this setting a larger fully powered clinical trial will be proposed An effective treatment or preventive measure for post-cataract surgery macular edema in patients with diabetic retinopathy would offer benefit to a large patient population nationally that is at high risk of vision loss
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