Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358423
Status:
TERMINATED
Last Update Posted:
2008-05-12
First Post:
2006-07-27
Brief Title:
The Effect of Macugen in Patients With Chronic Post-Operative Cystoid Macular Edema
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Pilot Study of the Effect of Pegaptanib Sodium in Patients With Chronic Post-Operative Cystoid Macular Edema
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 done to look at the effects of an experimental drug called pegaptanib also called Macugen for the treatment of swelling in the retina the light sensitive tissue in the back of the eye that can occur after cataract surgery Swelling in the retina can lead to blurry vision
The only treatment available for this condition is eye drops that decrease swelling in the back of the eye but eye drops may not decrease the swelling in everyone We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after cataract surgery
The only treatment available for this condition is eye drops that decrease swelling in the back of the eye but eye drops may not decrease the swelling in everyone We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after cataract surgery
Detailed Description:
While only 1 to 2 of people following cataract surgery develop visual acuity loss from chronic post-surgical cystoid macular edema CME this represents approximately 20000 individuals in the US each year and many more throughout the world No current drug or surgical treatment is very effective in the management of chronic post-surgical CME Topical non-steroidal anti-inflammatory medications such as ketorolac drops 4 times a day qid for 3 months have been shown to reduce the extent of fluorescein leakage on angiography in patients with this condition however compliance can be difficult not all cases resolve following this treatment the drop is not approved for this indication and it is unknown if this treatment has an effect that lasts beyond 3 to 6 months The fluorescein angiographic findings and the effects of ketorolac drops suggest that the condition is a result of increased permeability from inflammation and might resolve with a therapy that decreases abnormal vessel permeability 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 thereforepegaptanib may decrease vessel permeability and possibly decrease CME Pegaptanib has been shown to have some activity in reducing retinal blood vessel leakage in diabetic patients with chronic macular edema Macugen Diabetic Retinopathy Study Group A phase II randomized double-masked trial of pegaptanib an anti-vascular endothelial growth factor aptamer for diabetic macular edema Ophthalmology 20051121747-57 further supporting the hypothesis that it might be effective in other causes of chronic macular edema We plan to conduct a pilot study of the effects of pegaptanib up to 3 treatments of pegaptanib given as often as every 6 weeks for up to 12 weeks in subjects with chronic post-surgical CME If pegaptanib treatment is shown to be beneficial for this condition additional studies could be performed to prove long-term effectiveness in patients with chronic CME or even for prophylaxis for patients known to be at high risk of developing CME following ocular surgery
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