Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464581
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2007-04-19
Brief Title:
Lucentis for Treatment of Macular Edema
Sponsor:
Retina Institute of Hawaii
Organization:
Retina Institute of Hawaii
Study Overview
Official Title:
A Single-center Phase 2 Trial of Intravitreous Injections of Lucentis Ranibizumab in Subjects With Cystoid Macular Edema Secondary to Non-ischemic Retinopathy
Status:
COMPLETED
Status Verified Date:
2012-05
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:
FVF4153s
Brief Summary:
Cystoid macular edema CME is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions Over two million cataract extractions are performed each year with a reported incidence ranging from 15 to 69 resulting in an estimated 20000-130000 new cases of CME annually Clinical CME historically was associated with visual acuity of 2040 or worse with fluorescein angiographic evidence of macular edema in a classic petaloid pattern Angiographic CME physiologically signals an inflammatory process causing distortion of the outer plexiform layer which if not resolved quickly could result in non-repairable visual loss Topical periocular or intravitreal corticosteroids despite their associated side effects are the mainstay for pharmacologic treatment for patients with CME Their efficacy has never been demonstrated in a randomized controlled and blinded study
This is an open-label Phase II study of intravitreally administered ranibizumab in subjects with cystoid macular edema secondary to non-ischemic retinopathy as seen following cataract surgery with intraocular lens implantation
This is an open-label Phase II study of intravitreally administered ranibizumab in subjects with cystoid macular edema secondary to non-ischemic retinopathy as seen following cataract surgery with intraocular lens implantation
Detailed Description:
Vascular endothelial growth factor VEGF is known to be induced by hypoxia and has been implicated in the development of iris and retinal vascularization VEGF however is also known to be a potent mediator of vascular permeability in other tissues and may perform this function in retina
Immunohistochemical VEGF staining has been identified in patients with disorders such as aphakic and pseudophakic cystoid macular edema ocular inflammatory disease and infection VEGF was primarily localized within retinal neurons and within the retinal pigment epithelium in these cases In addition or in association with its role of inducing neovascularization Wet AMD and diabetic retinopathy VEGF may contribute to the breakdown of the blood-retinal barrier in a variety of disorders
Ranibizumab is a pan-VEGF A blocker that has been proven highly effective for the treatment of wet macular degeneration The underlying pathophysiology of both cystoid macular edema and wet AMD is VEGF overproduction
To date ranibizumab has been approved only for treating wet ARMD In this study we will explore ranibizumab for the treatment of cystoid macular edema It is hypothesized that this population will show dramatic improvement as the initial cause of VEGF production can be isolated to the surgical procedure and due to the fact that the retinal pigment epithelium is healthier in this population as compared to the macular degeneration counterparts
Immunohistochemical VEGF staining has been identified in patients with disorders such as aphakic and pseudophakic cystoid macular edema ocular inflammatory disease and infection VEGF was primarily localized within retinal neurons and within the retinal pigment epithelium in these cases In addition or in association with its role of inducing neovascularization Wet AMD and diabetic retinopathy VEGF may contribute to the breakdown of the blood-retinal barrier in a variety of disorders
Ranibizumab is a pan-VEGF A blocker that has been proven highly effective for the treatment of wet macular degeneration The underlying pathophysiology of both cystoid macular edema and wet AMD is VEGF overproduction
To date ranibizumab has been approved only for treating wet ARMD In this study we will explore ranibizumab for the treatment of cystoid macular edema It is hypothesized that this population will show dramatic improvement as the initial cause of VEGF production can be isolated to the surgical procedure and due to the fact that the retinal pigment epithelium is healthier in this population as compared to the macular degeneration counterparts
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