Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489840
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2007-06-20
Brief Title:
Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
Treatment of Chronic Central Serous Chorioretinopathy With Open-label Anecortave Acetate
Status:
COMPLETED
Status Verified Date:
2012-10
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:
CSC-AA
Brief Summary:
Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy
Detailed Description:
Central serous chorioretinopathy CSC is a disease of the macula characterized by loss of vision from exudation of fluid under the retina localized to the posterior pole Acute central serous chorioretinopathy CSC has been defined as an idiopathic detachment of the neurosensory retina in the macular region associated with a focal leak at the level of the retinal pigment epithelium on fluorescein angiography This area of leakage usually corresponds to a defect in retinal pigment epithelium RPE An acute episode of CSC usually resolves within 3 months from the time of onset with almost total restoration of the visual acuity
However in a more severe form of the disease chronic central serous chorioretinopathy there is diffuse decompensation of the RPE recurrent retinal detachments and progressive loss of visual acuity Indocyanine green angiography shows diffuse hyperpermeability of the choriocapillaris layer This chronic form of CSC is usually bilateral and often causes severe vision loss and impaired quality of life for the patient Chronic central serous chorioretinopathy can be defined on the basis of two factors 1 persistence of the detachment for more than 6 months and 2 chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium
The standard of care for acute CSC is observation for a period of up to 3 months If there is no complete resolution of the retinal detachment by 3 months focal laser photocoagulation therapy may be used to treat the area of leakage This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of the detachment However laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of the RPE thus rendering laser treatment ineffective Because of the limitations of laser photocoagulation for chronic CSC other treatments are currently under evaluation
Corticosteroids appear to be intimately related to the pathogenesis of the disease Exogenous corticosteroids have been shown to induce the disease via a variety of routes whether oral intravenous intranasal or intraarticular Secondly patients with endogenous hypercortisolism such as those with Cushings syndrome or with a type A personality are also at increased risk of developing the disease
The purpose of this medical research study is to evaluate Anecortave Acetate as an approach which may benefit patients with chronic CSC Anecortave acetate is a novel agent derived from the steroid cortisone but modified to eliminate glucocorticoid effects via removal of the 11β-hydroxyl group addition of a double bond at C9-11 and addition of an acetate group at C21 to increase ocular penetration and stability Anecortave acetate has recently been shown to possess anti-glucocorticoid effects in the eye such as in blocking steroid-induced glaucoma Anecortave acetate treatment to the eye has been evaluated for other disorders such as macular degneration and boasts an outstanding safety record with no adverse systemic reactions Ocular adverse events were mild such as subconjunctival hemorrhage
The concept of this protocol is that if Anecortave Acetate blocks the steroid receptors for glaucoma and prevents steroid-induced glaucoma perhaps it blocks the the steroid induced receptors involved in the pathogenesis of central serous chorioretinopathy If successful this modality of treatment may reduce the risk of progressive visual damage due to chronic CSC and perhaps even improve visual function without causing destruction to the overlying neurosensory retina
However in a more severe form of the disease chronic central serous chorioretinopathy there is diffuse decompensation of the RPE recurrent retinal detachments and progressive loss of visual acuity Indocyanine green angiography shows diffuse hyperpermeability of the choriocapillaris layer This chronic form of CSC is usually bilateral and often causes severe vision loss and impaired quality of life for the patient Chronic central serous chorioretinopathy can be defined on the basis of two factors 1 persistence of the detachment for more than 6 months and 2 chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium
The standard of care for acute CSC is observation for a period of up to 3 months If there is no complete resolution of the retinal detachment by 3 months focal laser photocoagulation therapy may be used to treat the area of leakage This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of the detachment However laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of the RPE thus rendering laser treatment ineffective Because of the limitations of laser photocoagulation for chronic CSC other treatments are currently under evaluation
Corticosteroids appear to be intimately related to the pathogenesis of the disease Exogenous corticosteroids have been shown to induce the disease via a variety of routes whether oral intravenous intranasal or intraarticular Secondly patients with endogenous hypercortisolism such as those with Cushings syndrome or with a type A personality are also at increased risk of developing the disease
The purpose of this medical research study is to evaluate Anecortave Acetate as an approach which may benefit patients with chronic CSC Anecortave acetate is a novel agent derived from the steroid cortisone but modified to eliminate glucocorticoid effects via removal of the 11β-hydroxyl group addition of a double bond at C9-11 and addition of an acetate group at C21 to increase ocular penetration and stability Anecortave acetate has recently been shown to possess anti-glucocorticoid effects in the eye such as in blocking steroid-induced glaucoma Anecortave acetate treatment to the eye has been evaluated for other disorders such as macular degneration and boasts an outstanding safety record with no adverse systemic reactions Ocular adverse events were mild such as subconjunctival hemorrhage
The concept of this protocol is that if Anecortave Acetate blocks the steroid receptors for glaucoma and prevents steroid-induced glaucoma perhaps it blocks the the steroid induced receptors involved in the pathogenesis of central serous chorioretinopathy If successful this modality of treatment may reduce the risk of progressive visual damage due to chronic CSC and perhaps even improve visual function without causing destruction to the overlying neurosensory retina
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